by Bill Sardi
Recently by Bill Sardi: Researchers Discover the Lean Body Hormone
Five years ago digital images of the human retina were sent to my office computer. I opened the file and saw something that had not been seen previously in modern medicine.
There were two images. The first image showed fluid accumulation at the back of the eye that had distorted vision as well as invasion by new abnormal blood vessels that threatened to permanently and irreversibly rob a patient of their vision. Lack of oxygen delivery to the back of the eye is what triggers the development of these invasive new blood vessels.
The second digital image was of the same eye taken only a few days later. The fluid leakage and swelling was gone. The retinal architecture was restored. The abnormal blood vessels had receded. More importantly, the patient's vision, which was near legal blindness in the first image, had improved to the point where the patient could almost pass a driver's license vision test.
This kind of remarkable turn-around in an elderly patient's vision is now made possible via injection of medicine that inhibits the development of abnormal blood vessels at the back of the eyes. But what made history is that these images on my computer were the result of an oral nutriceutical, Longevinex®, which I formulated. I now manage the company that makes that pill.
I had occasion to visit the eye center that sent me the images. The eye doctors there spoke of expanding a study to include more patients. Then suddenly, mum was the word. Eye doctors said they would not proceed nor inform the world that there was an option to needles having to be jabbed into the eyes.
Since that time the medical literature reveals the current drug used to treat this eye condition, called wet macular degeneration, doesn't work all the time. An estimated 1 in 6 treated-patients progress to registered blindness. In the past 5 years an estimated 150,000 patients have progressed to permanent and irreversible legal blindness that may have been spared this fate if they had known about Longevinex®.
Later doctors at the Veterans Health Center in North Chicago, Illinois picked up the ball and decided to see if Longevinex® could rescue the sight of patients who failed medical therapy and had no other options available. Most of these are patients in their eighth decade of life. In all instances, a non-FDA approved drug would be prohibited from being used. But Dr. Stuart Richer OD, PhD, and colleagues, were able to suggest patients acquire this nutriceutical on their own and use Longevinex® under existing "compassionate care protocols."
Earlier this year Dr. Richer reported on the first 17 Longevinex®-treated cases at a major eye research meeting. Sixteen of the first 17 Longevinex®-treated patients experienced measurable visual improvement, some experiencing rapid and dramatic restoration of functional vision (vision good enough to drive a car, thread a needle, etc.). Strikingly, not one ophthalmologist expressed interest in Longevinex®. One optometrist did call the manufacturer. There was no excitement over this scientific achievement because it would take money out of eye physicians' hands. Ophthalmologists are rewarded handsomely by Medicare to inject medicine into the eyes of these patients, making hundreds of dollars to inject medicine every 4 to 6 weeks.
The injectable drug currently used to treat wet macular degeneration costs $2000 and Medicare pays about $1624 of that. For comparison, Longevinex® costs ~$27/month. The FDA-approved drug is not much different than a prior version that costs just $50 per dose and that, according to a recent study, works equally well. The same manufacturer makes both drugs and only applied to the FDA for approval of the most expensive version for use among patients with wet macular degeneration. This represents a gouging of Medicare funds of unprecedented proportions.
Prior to approval of the $2000 version of this drug, the $50-version of this drug was being used on an off-label claim that it effectively treated this eye condition. Suddenly after many thousands of successful injections of the $50 drug, with the approval of the $2000 version, eye infections began to be reported among patients receiving the more economical drug. That is because 1-milligram doses of the $50 drug have to be withdrawn by syringe from a 300-milligram vial. There is a chance for contamination. So eye physicians have almost been forced to use the more expensive drug for fear of infection. Some eye physicians still inject the more economical drug for patients who have no insurance coverage.
Then recently a news reporter here in Las Vegas, where Longevinex® has its shipping headquarters, got wind of the story. Emmy-Award winning KLAS (CBS affiliate) reporter George Knapp began to investigate. His gripping two-part TV report can be viewed here. The report alleges modern medicine hid this scientific development out of its own greed.
Simultaneously my company, Longevinex,® has submitted a petition to the Food & Drug Administration to allow it to proceed with a human clinical trial without having to file an Investigational New Drug application. The petition claims it would take 2-years to determine if Longevinex® is safe and effective and cost $4.5 million to conduct that study. During that time an estimated 60,000 more senior Americans will progress to registered blindness.
The petition also pleads for the FDA to drop its customary requirement that Longevinex® be compared against an inactive placebo pill. That would be like having to prove parachutes work by having half of the jumpers wear no chute at all. Surely the placebo users would progress to blindness. Such a study would be unethical. Longevinex® should be compared against existing therapy, the failed injectable drug, which is a higher bar to jump over.
The question now is – how will the FDA respond? If it reacts the way it has in the past, it will issue a bulletin warning patients away from unproven dietary supplements. But Longevinex® is the only hope for thousands of patients. If it does not pose a risk for side effect, what harm could come from using it? Longevinex® has been used in relatively safety by thousands of consumers over a period of 8 years, making it safer than many FDA-approved drugs on their first day of use. Longevinex® has even conducted animal and human toxicity testing, something rare for a dietary supplement.
And recall, the $50-injectable drug was used and still is used as an unapproved drug. So, in the face of so many patients losing their sight, why wouldn't the FDA grant provisional approval for a non-FDA approved nutriceutical given so many senior Americans will drift into permanent and irreversible blindness otherwise?
Longevinex® is not applying for general use for patients with wet macular degeneration. It is petitioning for use among the estimated 30,000 patients who have failed the current standard of care — injectable drugs.
For far too long modern medicine has dictated what patients will receive. In this case, it's possible a less problematic and more economical alternative exists, at least for those who have failed injectable drug treatment or who don't want a needle jabbed into their eyes. Thanks to the news media, patients are learning of an alternative. As a manufacturer, we cannot make any claim that a dietary supplement prevents, treats or cures any disease. But under the 1st amendment to the Constitution, truth becomes known. Stay tuned for further developments. Already, in the first day after the news report, pretender products are sprouting up online to misleadingly portray their product as the one shown on a TV news report without any conscience over whether their product is effective. That will surely provoke a response from the FDA.