Life-Saving Advances Held Up by FDA

I’m confronted with a very serious, sobering, shocking, and yet relevant question.

Which is proving to be more deadly to Americans, in real and physical terms — the WMD or the FDA?

Jihadist weapons of mass destruction have claimed over 3,500 lives in Iraq, some 3,000 on 9/11 on our own soil, and many hundreds more in attacks throughout the civilized world. Meanwhile, constant and lengthening delays by the Food and Drug Administration in approving new and vital medicines have sacrificed 10 times that many lives, and likely even more. So which is proving more deadly? The WMD or the FDA?

We Americans all grieve over the tragic loss of young and promising life in the war with the Islamic jihadists. Even though statistics show we’ve suffered even more loss of life right here in our streets and homes, from criminal violence and traffic accidents — and likewise from smoking and obesity and other avoidable causes — a look at the sheer numbers shows that our population is much more threatened by another destructive element that is right in our midst, and supported by our tax dollars!

As so often has happened in our government, the Food and Drug Administration and the Federal Trade Commission were established to protect our citizens from unscrupulous marketers or unhealthy foods and unproven medicines — good ideas for good motives.

Yet now we’re needing to find a way to throttle back the bureaucratic authority of the bloated FDA, and the entrenched regulators who have assumed dictatorial powers unto themselves. For reasons impossible to understand, while other nations speedily implement new medical discoveries and make them available to ill and desperate citizens who need them, our agency takes three to 10 to even 15 years to clear a new drug or therapy!

Startling facts on all this are available from the Competitive Enterprise Institute. Headed by academician and activist Fred L. Smith, this group makes a mission of truly looking out for the consumer and the American taxpayer, to try to guarantee we’re getting what we’ve been promised, and what we’re paying for.

The CEI has established that thousands of American doctors believe delays by the FDA in approving new medicines are costing human lives. In fact, this is the majority view of specialists who treat such life-threatening conditions as cancer and heart disease. The CEI calls the inaction and delays “deadly overcaution.”

Examples:

35,000 Americans died of kidney cancer during the three and a half years that the FDA took to approve Interleukin-2 as the first treatment for this disease. By the time the FDA acted, nine European countries had already made the drug available.

After an FDA-mandated delay of seven years, beta-blockers (used for heart problems and hypertension) were finally made available. A scientist at the Tufts University Center for the Study of Drug Development says as many as 119,000 people who could have been helped died while the FDA dawdled.

A simple suction-cup device known as the CardioPump has been shown to increase survival rates when used in CPR for victims of cardiac arrest. It’s used already in a number of countries worldwide, and it poses no additional risks to patients. Yet the FDA so far has refused to permit its use.

The CEI, on our behalf, has interviewed doctors on the front lines of the battle against life threatening diseases; they’ve surveyed oncologists, cardiologists, neurologists, and many others. And they say a sizable majority of America’s leading specialists are convinced the FDA is tragically and unjustifiably slow in approving life-saving drugs.

Consider:

It now takes an average of 14.8 years for a new drug to be tested and earn market approval. Thanks to FDA-imposed delays, that is double what it took just a generation ago. Why? Shouldn’t this agency have gotten better over these years, and not slower and less efficient?

Across the street at the Federal Trade Commission, another government regulator who is privy to stark facts has said FDA-imposed regulations “increase patients’ suffering by denying them new drugs.”

It now costs an estimated $800 million just to get a new drug on the market, according to a Tufts University study — almost four times higher than in 1987! Isn’t it clear something is badly haywire?

Is it any wonder that almost all medicines cost unbelievable prices? It’s too easy to blame the pharmaceutical companies, but consider: drug development costs have skyrocketed during the last 20 years, the time it takes for clinical testing has greatly increased, fewer drugs are being approved, and the number of applications to the FDA for marketing approval has been decreasing for more than a decade. And the agency is requiring ever larger numbers of patients in clinical trials—all of this discouraging laboratories from even making the effort for clearance.

So what can be done about this lethal mess?

I suggest we contact The Competitive Enterprise Institute (http://www.cei.org ), read their mission statement and find out what they’re doing to put powerful pressure on the FDA — who are our paid employees, after all.

CEI takes the position, and I agree wholeheartedly, that this agency should not have the power to completely ban drugs and medical devices. Yes, they can sound warnings (much like every drug maker does while advertising their products, even Viagra with its notorious “4 hours” caveat), but they should let the patient and the doctor make the final decision about the treatment and medicines that may save the life!

Should a drug approval go through a 100,000 page application process? The Competitive Enterprise Institute says no — not after years of actual testing and documentation! This is overzealous regulation, the aforementioned “deadly caution.” It needs to be quickly and thoroughly re-evaluated, trimmed drastically, and made streamlined.

None of this will happen without a struggle; entrenched power and bureaucracy are tenacious. But the lives we save may be our own.