FDA ineptness hurting people everywhere

By controlling which drugs are allowed on the market, the U.S. Food and Drug Administration has extorted a large toll in drug costs, drug availability and human life throughout our nation -- greater New Smyrna Beach no exception.
The FDA has greatly delayed the introduction of some useful drugs and totally eliminated the introduction of others.

It is estimated that 85 percent of the cost of drugs is caused by the FDA procedures.

Furthermore, the average time to market for a new drug is about 14 years. Before the FDA acquired such a big role in the drug approval process the average time to develop a new drug and get it to market was about four years.

This huge time delay, of course, is what makes the price so high and keeps many potential developers of new medicines out of the business.

The end result is that not only are Southeast Volusia citizens paying 6 to 7 times as much for their medicines but, worse yet, the medicines they need to survive are not yet developed or may never be developed.

According to some estimates, about five million Americans have had their lives shortened because of the FDA. This translates to about 300 local residents who have had their lives shortened due to the FDA.

Now it may be true that the FDA manages to keep some bad or ineffective drugs off the market and thus save a few lives and some suffering. However, the cost of this oversight exceeds the benefit many times.

First, more years of life are lost in the process that are saved. Second, the additional cost of medicines is astronomical. Third, the state of the art in medicine is set back many years.

A smart aleck might say that if the FDA had control of the development of electronics, we would still be waiting for the home computer and it would cost at least 10 times as much when it finally arrives.

Why does the FDA act in a manner that so obstructs the development of medicines and medical techniques? Two main reasons come to mind.

First, it is a government agency so it would be totally unreasonable to expect it to work in an efficient manner. However, the incentives are very heavily biased toward slowing down the process. The FDA is never rewarded for getting a useful drug to market quickly while it is criticized if a bad drug gets to market. Therefore, the fewer medicines they approve the less risk they take. We may be lucky they approve any.

Second, the FDA likes to flex its’ authority and make the “evil” drug companies jump through hoops just to make sure they know who’s the boss. This leads to drugs being delayed for completely capricious reasons.

Under these circumstances, FDA personnel behave like any other rational person put in that position. The only cure is to quit putting people in that position. Abolish the FDA!

Why aren’t people screaming about this situation? First, dying and suffering due to the FDA cannot be identified specifically. I know people who have died of diseases for which cures could not be researched because of the excessive costs caused by the FDA. However, I can’t say that without the FDA, cures would have been found.

Citizens of New Smyrna Beach, Edgewater and Oak Hill know people who died of heart problems while the FDA kept beta blockers off the market for years. Many of these people could have been saved but we don’t know which ones.

We know that in the statistical sense, many people are dying because of these delays, but statistics don’t tell us exactly who these people are.

Consequently, we are kept from becoming really angry.

Another factor is that the people who really understand the problems posed by the FDA don’t dare say a word. If a spokesman for Merck or Pfizer were to sound off about what the FDA is doing to America’s health, Merck or Pfizer would have their new drugs put on the ultra super slow approval track (instead of the very slow track) and they would go under.

Another incentive to say nothing is that the slow drug approval keeps competition from forming. Many a small drug company has gone bankrupt while waiting for drug approval.

No doubt the large drug companies appreciate this but would never admit it. Note that by nature it is the small companies that have a disproportionate share of the new ideas.

There is no need to have an FDA that has such broad powers. We went until the early 1960s without much FDA action and things went well.

With few exceptions, drug companies do not knowingly put bad drugs on the market and American doctors are not fools -- at least not in the long run.

One glaring example where the public was harmed by a drug manufacturer was with the OxyContin scandal that led to the 2007 convictions of Purdue Pharma LLC executives Michael Friedman, Howard Udell and Paul Goldenheim for misleading physicians and patients into believing that their Oxycontin product was less addictive and less likely to be abused than other narcotics.

But they spent no time in jail, thanks to a plea bargain brokered by Rudy Giuliani, with the parent company agreeing to pay $634 million in fines to the government.

The FDA is actually an insult to the American medical profession with its long tentacles, and as the OxyContin criminal case showed, calls into question its real oversight abilities.

The conclusion is that if the FDA were to suddenly disappear tomorrow, everyone would benefit, especially around here, because of our aging population.