We now have the results of over ten years of research and there is some good news. Using this research the NeuroTCA has seen a 92% success rate for helping patients with the pain associated with P.N. The use of light waves to stimulate tissue repair has recently become recommended therapy by the America Diabetic Association.The even better news is that research shows that this breakthrough treatment is painless, non-invasive and is effective in helping to restore function in all types of P.N. without the side effects of drugs or surgery.

When patients visit a clinic, they should give them an exam to determine the function of their nerves in the legs, feet, toes and hands. If the exam reveals neuropathy, acare plan is devised to rehabilitate the nerves and reduce discomfort. “We have seen this treatment changing people’s lives,” Dr. Carpenter said. “People suffering from peripheral neuropathy pain can have a low quality of life as the pain touches everyaspect of their existence.” One patient joyfully exclaimed after completing her treatment program, “I got my life back!”

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Doctors can legally prescribe drugs for "off-label" uses not approved by the FDA, but drugmakers cannot market drugs for such off-label uses. Why is it OK to prescribe drugs for these uses? Well, the paradigm for off-label prescribing is that doctors do it when nothing else has worked for a patient who is either terminally ill or otherwise in desperate need of treatment. In those scenarios, it's hard to argue with giving doctors the ability to experiment with whatever drugs they think might help. (In truth, off-label prescribing is so common that this extreme scenario hardly represents the typical situation.) Marketing drugs for that kind of experimental use, however, is obviously problematic and thus banned.

Too Great a Temptation

The difficulty for many pharmaceutical companies, however, is that generally they've proven a given drug to be safe and effective only as a treatment for a very specific or relatively uncommon condition, such as epilepsy. If it's used to treat only that condition, the drug's profit potential is limited, yet the extensive clinical work required to prove safety and effectiveness for additional uses is so time-consuming and expensive that drugmakers don't want to do it.

Instead, they do small-scale studies that suggest a drug might be safe and effective for an unapproved use, and they inform doctors about the limited, if promising, data. (Of course, in this case, the data didn't suggest Neurontin was effective for the off-label uses.) Informing doctors about the data is legal, only if drugmakers don't cross the line to active promotion for those uses, which unfortunately, drugmakers often do. The profit potential of off-label marketing can be just too great a temptation.

In the Neurontin case, off-label prescriptions reportedly accounted for 15% of its sales in its first year on the market, 1994, and had grown to 94% of its sales in 2002. That meant that by 2002, $2.12 billion in Neurontin sales came from prescriptions for uses not proven to be either safe or effective.

Despite the newness of the RICO verdict, the finding on Pfizer's conduct isn't really news. In 2004, Pfizer (through Warner-Lambert, which Pfizer acquired in 2000) paid $430 million to settle criminal and civil charges that it illegally marketed Neurontin in the same ways addressed in the RICO case. Just because the guilty verdict in the RICO case is unsurprising, however, it doesn't mean that it's not a big deal for Pfizer. Many other Neurontin-marketing cases have been filed, and Judge Patti Saris, who oversaw the trial decided on Thursday, is not only in charge of them but she ruled last year that this trial's results may be binding on those cases.

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