Critics have been laying it on thick, saying that the Food and Drug Administration's (FDA) response to potentially harmful drug side effects has been sub-par. Ever since the 2004 Vioxx debacle, the agency has sought to tighten its drug safety oversight--though it doesn't seem to be doing much good ...
That's because for more than a year before a scientific journal reported Viagra had been linked to a rare form of blindness in some men, an FDA safety officer made the same observation from evaluating adverse reports and told her supervisors to issue an advisory of the effect to doctors and patients.
FDA supervisors listened to her advice, but did absolutely nothing about it.
The safety officer's experience was detailed in a letter to Acting Commissioner Lester Crawford from Sen. Charles Grassley (R-Iowa), chairman of the Senate Finance Committee, investigating the FDA's inability to protect the public from potentially harmful drugs. Grassley argued that the agency moved far too slowly on an emerging safety concern.
What Does Pfizer Have to Say?
In light of the commotion, Pfizer (which makes Viagra) claims the side effect has not appeared in any of its 103 clinical trials and that the 23 million users have not reported any increased risk of blindness.
Even though Pfizer has stated not to believe there is a relationship between taking Viagra and blindness, the company still plans on adding information about the possibility to its label.
And it wasn't until after the scientific journal highlighted a possible link between the drug and blindness that an FDA spokeswoman stated that the agency is taking the issue very seriously and is working with the sponsors to make sure the public is notified of the risks.
Reported Proof
While the FDA has said 38 Viagra users and five users of other impotence drugs reported a sudden and permanent blindness in one eye called non-arteritic anterior ischemic optic neuropathy (NAION), according to CBS News:
Over the last four years, more than 800 patients and doctors have reported eye problems to the FDA after using Viagra.
Of those reports, there have been more than 140 cases of partial or total blindness.
San Francisco Chronicle July 1, 2005
It is obvious to nearly everyone that some serious changes need to be made at the FDA. But rather than just throw rocks at this organization, it is my intention to help solve the problem.
In that effort, I am pleased to announce an alliance with one of the most courageous health leaders of the 21st century: Dr. David Graham. He has helped write new legislation called the Grassley Dodd Bill that is currently held up in committee. It is a radical bill that should help transform the FDA back to its roots and really protect the public safety. It would set up a new independent Center inside the Food and Drug Administration (FDA) to review drugs and biological products once they are on the market.
The bill addresses the fact that office of new drugs carries too much sway over the FDA’s drug-safety apparatus. Today drug makers have the ability to negotiate with the FDA officials who approved their drugs to begin with when the FDA considers corrective action By creating a Center for post-market review, this legislation puts you, the American consumers where you belong at the FDA, and that’s front and center.
I don't ask you to write your congressman frequently, but this one is worth it. You can help save some lives by helping to increase pressure to change the way the FDA is run. The drug companies do NOT want this bill passed and they have the largest lobby in Congress so we really need all the help we can,
You can find out how to contact your Congressman by going to the following URL:
All you need to do is write a simple short note telling them how you feel the FDA is critically broken and you believe that the new proposed legislation would really help improve that.
If you want to review the entire bill I put it up on my site.
Getting back to the Viagra issue, please remember that there are many other effective non-drug solutions for impotence.
Four Healthy Alternatives For Treating Sexual Dysfunction
Sexual arousal occurs not just in the genitals, but also in the whole body, especially the brain. For men, it actually begins when the brain sends impulses down the spinal cord and out to the nerves that serve the penis. These impulses trigger the production of nitric oxide. The neurotransmitter that causes the sexual message, in men and women, is acetlycholine (ACH). With too little ACH, sexual activity goes down. One way to safely and effectively enhance ACH levels in the body is to take choline supplements (1,000-3,000 mg) and vitamin B5 (500-1,500 mg).
Studies have proven that active men who engage in regular physical activity lowered their risk of experiencing erectile dysfunction. Exercise helps ward off impotence the same way it can prevent heart attacks, by keeping blood vessels open. So check out my most recent exercise guidelines to get started on a routine today.
Optimize your diet based on your body's unique metabolic type. We each have a unique nutritional type and each type demands varying ratios of macronutrients (fats, proteins and carbohydrates) to function optimally. My Total Health Program provides a deeper understanding of eating the right foods for your specific nutritional type and includes a test and the means to learn and understand your own metabolic type.
I also recommend reading the recent article that Dr. Douglas MacKay wrote for the site, The Secret Solution to Male Virility.
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The FDA "Foxes" Keep Guarding the Drug Safety "Henhouse" The Blinding Truth Behind Impotence Drugs Impotence Drug May Promote Heart Attacks
The FDA "Foxes" Keep Guarding the Drug Safety "Henhouse"
The Blinding Truth Behind Impotence Drugs
Impotence Drug May Promote Heart Attacks