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[F134]Fda Device Approval Process
by Mark Ramirez, Mar
Years and years the FDA has told the American public that they are here to serve in our best interest. They have told us that the reason we cannot import medication from Canada is because it is not safe. They have told us the reason that America doesn't have price controls is because they want to promote the creation of truly new innovative drugs. What they failed to mention is how none of these claims are true, and rather than serving as a guard against potential hazards and dangers, they are really here to utilize there position in order to manipulate the system for their own personal gain.

The best example that displays several different types of corruption that are taking place in the FDA is the case of Vioxx and the COX-2 inhibitors. COX-2 inhibitors are a class of drug that help to relieve the symptoms of arthritis. Vioxx had been heavily promoted to both doctors and the public and was used by over 2 million people giving it a yearly sale of over $2.5 billion dollars. Suddenly, on September 30, 2004, Vioxx was withdrawn from the market after a clinical trial showed that it more than doubled the risk of heart attacks and strokes.

The FDA failed to mention that they had pushed Vioxx through the approval stage so fast, they failed to do the necessary studies to prevent harm to the American public. They made one mistake, and they corrected it by getting Vioxx off the market, right? Well they followed it up by going against the better judgment of most professionals in their field by leaving all the other COX-2 inhibitors like Celebrex and Bextra on the market.
Strike two. It didn't take long and within several months there were reports that the other drugs were experiencing the same problems and they were taken off the market as well.

In lieu of all this controversy, the FDA created an advisory panel to look into the case. The panel consisted of two advisory committees; one for arthritis and the other for drug safety. After several days of deliberation, the two panels concluded by a narrow margin that even though there was no doubt that the COX-2 inhibitors increased both heart attacks and strokes, the benefits outweighed the risks and all the inhibitors would be allowed to return to the market just with stronger warning labels.

After the fact, research into the FDA cases revealed that many members of the FDA advisory panels for both the original approval as well as the committees that voted to re-release the drugs back on the market, were paid consultants for the drug companies. When a member has financial ties to a company that is up for approval or review, that member is supposed to excuse themselves from the decision. In the meeting for the approval of Vioxx for of the six members including the chairman, had financial ties to Merk, the maker of Vioxx. Even more conspicuous is that according to the New York Times, on the panel that reviewed the COX-2 inhibitors to determine if they would be placed back on the market, ten of the members that voted had financial ties to one manufacturer. Oddly enough, the vote was nine to one in favor of Vioxx.

It is clear that the easy standards of approval for drugs, the sluggish response of the FDA to the clear danger of a drug on the market, and the undeniable conflicts of interests of the members of the FDA all play a part in the grand scheme of stealing and harming the American public. Why keep feeding a corrupt system that doesn't care about your well being and is just there to see how much money they can make off of you? Instead of buying your prescription medication for here, look to alternative markets in Canada and Mexico that have price restrictions. A good resource for locating the cheapest and safest medication is PremierMexicanPharmacies.com. Visit this Consumer Advocacy website for more information on ordering from a reliable<---****HYPERLINK****--->?http://www.premiermexicanpharmacies.com?>Mexican pharmacy.

Years and years the FDA has told the American public that they are here to serve in our best interest. They have told us that the reason we cannot import medication from Canada is because it is not safe. They have told us the reason that America doesn’t have price controls is because they want to promote the creation of truly new innovative drugs. What they failed to mention is how none of these claims are true, and rather than serving as a guard against potential hazards and dangers, they are really here to utilize there position in order to manipulate the system for their own personal gain.

The best example that displays several different types of corruption that are taking place in the FDA is the case of Vioxx and the COX-2 inhibitors. COX-2 inhibitors are a class of drug that help to relieve the symptoms of arthritis. Vioxx had been heavily promoted to both doctors and the public and was used by over 2 million people giving it a yearly sale of over $2.5 billion dollars. Suddenly, on September 30, 2004, Vioxx was withdrawn from the market after a clinical trial showed that it more than doubled the risk of heart attacks and strokes.

The FDA failed to mention that they had pushed Vioxx through the approval stage so fast, they failed to do the necessary studies to prevent harm to the American public. They made one mistake, and they corrected it by getting Vioxx off the market, right? Well they followed it up by going against the better judgment of most professionals in their field by leaving all the other COX-2 inhibitors like Celebrex and Bextra on the market.
Strike two. It didn’t take long and within several months there were reports that the other drugs were experiencing the same problems and they were taken off the market as well.

In lieu of all this controversy, the FDA created an advisory panel to look into the case. The panel consisted of two advisory committees; one for arthritis and the other for drug safety. After several days of deliberation, the two panels concluded by a narrow margin that even though there was no doubt that the COX-2 inhibitors increased both heart attacks and strokes, the benefits outweighed the risks and all the inhibitors would be allowed to return to the market just with stronger warning labels.

After the fact, research into the FDA cases revealed that many members of the FDA advisory panels for both the original approval as well as the committees that voted to re-release the drugs back on the market, were paid consultants for the drug companies. When a member has financial ties to a company that is up for approval or review, that member is supposed to excuse themselves from the decision. In the meeting for the approval of Vioxx for of the six members including the chairman, had financial ties to Merk, the maker of Vioxx. Even more conspicuous is that according to the New York Times, on the panel that reviewed the COX-2 inhibitors to determine if they would be placed back on the market, ten of the members that voted had financial ties to one manufacturer. Oddly enough, the vote was nine to one in favor of Vioxx.

It is clear that the easy standards of approval for drugs, the sluggish response of the FDA to the clear danger of a drug on the market, and the undeniable conflicts of interests of the members of the FDA all play a part in the grand scheme of stealing and harming the American public. Why keep feeding a corrupt system that doesn’t care about your well being and is just there to see how much money they can make off of you? Instead of buying your prescription medication for here, look to alternative markets in Canada and Mexico that have price restrictions. A good resource for locating the cheapest and safest medication is PremierMexicanPharmacies.com. Visit this Consumer Advocacy website for more information on ordering from a reliableMexican pharmacy.

Article Source : Pg. 230

Mark Ramirez has sinced written about articles on various topics from Health, Laptops and Birth Control. For more information visit our blog: .. Mark Ramirez's top article generates over 14800 views. to your Favourites.
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