A drug has been developed that is a true miracle of modern pharmacology. I say this because it can reduce deaths for patients with Congestive Heart Failure (CHF) as much as a ten-thousand- dollar defibrillator; it is perhaps the most effective drug we have to help treat patients with resistant hypertension; it can correct low potassium levels and can even cure some types of baldness, acne, and problems with facial hair in women. Some large studies have even shown it to reduce the spillage of protein in the urine. And for this miracle drug, we do have to thank Big Pharma.
The drug I am describing, best known as Aldactone, or spironolactone by its generic name, is an FDA approved drug that was not developed recently but has been on the market since 1959! And the cost of this drug — a drug that likely can save thousands of lives and help millions of others — around 10 cents a pill. Ten Cents!
If we look at the other major drugs that save lives in congestive heart failure cases we find a similar theme. The only class of drugs that help patients with CHF were developed decades ago, and cost pennies per pill.
Beta blockers, an important type of medication that saves lives in patients with CHF, were first developed in the 1960s by a James Black, an English scientist who was eventually awarded the Nobel Prize in Medicine for his discovery.
Angiotensin Converting Enzyme Inhibitor (ACE Inhibitors), first marketed as Captopril, was discovered in 1975 by scientists analyzing the ingredients of poisoned arrows used by tribesman in Brazil. The natives, or course, received nothing for their discovery. Along with beta blockers and spironolactone, ACE inhibitors make up a triad of medications used to improve symptoms and mortality in patients with heart failure.
Other drugs, specifically drugs that push weak hearts to work harder, with the exception of one, have all been shown to increase mortality in patients being treated for heart failure. The drug that seems to have a neutral outcome, and at least doesn’t kill the patient, was first used to treat patients in 1785 after William Withering reported that extract of the leaf of the plant Foxglove helped patients with what at that time was called dropsy; a term likely used for patients with heart failure and a fast and irregular rhythm. The modern derivative of this drug is Digoxin and it continues to be used in patients with heart failure, especially those with an irregular rhythm known as atrial fibrillation.
The most often used diuretic for patients in and out of the hospital remains a medication best known as Lasix (generic name furosemide). This drug was developed and marketed over forty years ago, and in its oral form also costs pennies a day. Big Pharma, in a race to make big money, has marketed what they claimed were more potent and safer drugs, to help remove excess fluid in patients with CHF. One such drug, Natrecor, costs over $500 dollars for a single dose and was eventually found to have NO benefit over its pennies-a-day alternative, Lasix. I wouldn’t feel badly for the makers of this drug, Scios Inc. (purchased by Johnson and Johnson), however, since they managed to sell billions of dollars of this drug after the FDA, in 2001, allowed it into the marketplace before trials showed that it was no more effective than the usual therapy plus placebo.
Some of the physicians on the FDA panel were known to have profited by lecturing for big pharmaceutical companies, including the panel chairman, Dr. Milton Packer.
Dr. Steven Nissen, who many of us now know as an outspoken critic of Big Pharma’s cozy relationship with physicians, may not have had a similar view in 2001 when he stated the drug was effective and recommended its approval, even while no trial data would ever show it prevented any deaths.
When Scios first marketed this drug they had their crafty marketing staff call on doctors to advise the physicians on how they could earn big dollars opening intravenous therapy centers. There, instead of using simple diuretics that cost pennies, they told doctors how they might create complex visits that included prolonged intravenous therapy with Natrecor. I recall the salespeople coming to my office with complex charts showing how I could earn thousands of dollars each month for this and I also recall asking them to leave and to never return. Too many, as you might have guessed, profited through this scam.
The cost of a two day treatment with Natrecor, a drug that provides ZERO benefit for mortality in patients with CHF, is roughly the same as a ten year supply of the beta-blocker, ACE inhibitor, spironolactone, and furosemide, recommended to significantly reduce symptoms, hospitalizations and death from congestive heart failure.
In closing, I want to thank Big Pharma, or at least the Big Pharma that developed these medications fifty-years ago, for helping us treat patients with Congestive heart failure. As for Scios Inc., you can judge for yourselves where their priorities lie.