Why aren’t Hypertensive patients mad?

Renal Denervation: Exciting Promise for the Treatment of Drug- Resistant Hypertension. Why Aren’t Hypertensive Patients Mad? Another Reason for the Doctornaut Act

Currently, in the United States alone there are approximately 76 million  hypertensive patients, about 9 million of whom are resistant to drug therapy making them highly vulnerable to heart attacks, strokes and heart failure the latter of which is becoming increasingly common in the aging population, particularly diabetics. Drug resistance is defined as a patient whose blood pressure is not adequately controlled with three drugs, one of them being a diuretic.

Let’s make a conservative estimate regarding the number of diagnosed drug- resistant patient visits made over the last 50 years and assume a prevalence of 5 million patients times five visits per year which amounts to 1.25 billion doctor visits where treatment was and remains unsuccessful. The actual absolute figure of the total number of individual patients is tough to come by but it is obviously substantial. Ask yourself, “How many patients have had heart attacks, strokes let alone kidney failure and died because of the lack of effective therapy?” To my knowledge, this has not been precisely quantified. Also, ask yourself, “Because of the adverse effects of powerful antihypertensive drugs, what impact has it had and continues to have on the quality of life not only on the patients but their families?” The amount of suffering due to adverse effects also has not been quantified. But premature death and suffering is the enormous price that has been paid.

It has been known for years that there’s a connection between the brain and kidney regarding the regulation of blood pressure. Over a half a century ago, a surgeon conducted an operation in hypertensive patients cutting nerves leading to the kidney or renal denervation. Blood pressure was significantly lowered but the procedure itself led to unacceptable complications. Instead of pursuing this exciting lead, the medical- health community let it drop and, instead, opted for effective pharmaceutical drugs which began to be increasingly available to doctors. Yet even with these effective pharmaceuticals, drug resistance has continued.  A couple of decades later in animal studies conducted in rodents, sheep, pigs and dogs, using certain techniques, results were published reporting that renal denervation  significantly lowered blood pressure.  Recently, over one-half a century after the initial surgical procedure and one-quarter of a century after the animal studies, there is finally potentially good news for drug- resistant hypertensive patients. New technology for renal denervation in patients has been shown to be highly effective in lowering drug-resistant blood pressure. It involves inserting a catheter into a groin artery and guiding it to the renal or kidney arteries. Then a wire with an electrode head is placed into the catheter and guided to the arteries and, by the use of radiofrequency, the nerves in the arteries are destroyed. The procedure takes about 30 minutes and appears to be safe. In a preliminary clinical study in drug- resistant hypertensive patients not only was blood pressure significantly lowered but for over a three year period. Medtronic, a U.S. medical device company, is now conducting clinical studies in the U.S., and FDA approval is expected within a few years. (FYI, there are a number of competitors trying to develop other medical devices or techniques).   But a word of caution: There is a possibility that some unforeseen complications may happen due to denervation itself.  To diminish this concern, patients who receive a kidney transplant where denervation occurs have not suffered significant adverse effects. If this medical procedure is approved, then the costs of treatment of millions of patients will be substantially reduced- another bit of good news!

Now here’s the point: If I or my loved ones were a drug -resistant patient I’d be mad as hell. After the initial surgery way back in 1953, our medical system should have produced innovators to develop effective medical devices. But in my long experience there is an absence of anger by patients and also doctors in all disease categories, and this sin of omission is one crucial factor why we don’t have better therapies and cures. One unrecognized cause for the lack of anger reason rests on the shoulders of the media. Reporters of all sorts rarely address the causes which block medical discovery in sufficient depth. But anger is huge force which drives our society to action in many walks of life. AIDS patients were very, very angry about the absence of therapies and became persistent advocates to establish a vigorous AIDS R&D program. And look what happened! The NIH and pharmaceutical industry jumped into action and, as a result, today there are highly effective therapies available for this once almost 100% fatal disease.

Years ago, I appeared on the Good Morning America television show to debate a top FDA official regarding why the famous movie actor, Rock Hudson who was an early AIDS victim, had to go to Paris to be treated with a new experimental anti-virus drug instead of being able to be treated in the U.S. (A video of the interview is posted on www.fimdefelice.org). That afternoon I flew to Indianapolis for a meeting on magnesium and diabetes. What a surprise! Waiting for me at the airport was a group of AIDS patients along with supporters with a placard reading, “Thank you, Dr. DeFelice.” I never did find out how they knew- they wouldn’t tell me! – I was coming but I was highly impressed by their energy. This was an isolated instance which reflected a general successful AIDS crusade- and it was a crusade. This would never have happened with drug- resistant hypertensive patients or many other disease-disability afflicted groups.

Fortunately, there still are individual crusaders dedicated to conquering disease which may be an indication that our country is ready to take up the challenge to speed up medical discovery. Nancy Goodman lost her child due to cancer. She then founded Kids v Cancer whose mission is to increase pediatric cancer research. She is the force behind the recently passed Creating Hope Act which will accelerate the availability of cancer therapies to children.

As a reminder, on the FIM, Foundation for Innovation in Medicine website, www.fimdefelice.org, I have proposed the Doctornaut Act which will markedly accelerate the discovery of new medical breakthroughs for most diseases and disabilities from highly effective therapies to cures. Get angry!

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