GETTYSBURG MEDICAL NEWS
The Clinical View
by P.E. Hoffsten, MD
8 May 2002

TOPIC: MEDICAL TERRORISM, 2002.

    I wrote a previous column on medical terrorism but it needs to be updated. A favorite activity of some journalists, the TV networks, and sensationalistic newspapers is to publish articles to alarm and alert the public in regard to one medical crisis or another. These articles are usually slanted, over emphasizing some information and neglecting many pertinent points. So many times, the articles are published panic the public, as opposed to inform.

    In the past week, a nationally syndicated news service published commentary on an article that had appeared in the Journal of the American Medical Association. The Journal of the American Medical Association article presented information that was basically a truism. The article pointed out that when new medications come on the market, previously unencountered side effects might occur. This is true of every commodity in our society. When a new computer or new car or a new type of food or a new type of clothing or a new type of building material first comes on the market, it is not tried and true until it has been used for awhile. Most certainly the same thing is true for medications. I wouldn’t think that this would be a surprise to anybody.

    One of the headlines, though our nationally syndicated news service stated, “New drugs are dangerous”. There is a gigantic book call the Physician’s Desk Reference. It is a list of all of the commercially available prescription medications used in the United States. The book lists the indications for the use of the drugs, the side effects one might expect, the precautions that should be used, and the appropriate dosage for each medication. Some drugs also carry a “black box” warning to alert health care providers to important but unexpected side effects a medication may have. The article that appeared in the Journal of the American Medical Association pointed out that an increasing number of drugs have “black box” warnings in the past several years suggesting that the Food and Drug Administration has been lax in allowing new medications to come on the market. Notice what a grabber the term, “black box” warning is. The implication is that if a drug has a “black box” warning, it must really be dangerous. Nothing could be further from the truth.

     In fact, the Food and Drug Administration is becoming increasingly stringent in their requirements for a drug to be released to the market for sale in the United States. There are many medications available in other countries that our Food and Drug Administration has not felt safe for the United States. Some may remember the thalidomide induced birth defects that occurred in other countries several years ago; our FDA never approved thalidomide for USA consumption.   The expense that a drug company encounters to bring a new drug to the market is huge and is reflected in the very high prices that new drugs cost. Drug companies charge the amount that they do for their medications in order to recover the development and research costs required by the Food and Drug Administration.

    To clarify an important point, drug companies often carry out what is called a post-marketing study. In this type of study, a very large number of patients are evaluated using the new drug after it has come on the market. These patients are evaluated in the context of the real world where patients go to their local doctors. Those local doctors are enlisted by the drug companies to try the medication cost free for people who might well benefit from it. Those patients then have blood tests and various other examinations done to search for side effects and better characterize the drug. “Black box” warnings are coming from these studies. Thus, a “black box” warning is not a laxity on the part of our Food and Drug Administration; it is a measure of their effectiveness in continuing to insure the safety of medications used in the United States.

     The reason for a written health care provider prescription is that the lay public is not educated enough in regard to the effectiveness, usefulness, and safety of medications. Using medications isn’t the same as buying candy bars, bread, or a new shirt for which you don’t need a prescription. Instead, our Food and Drug Administration requires a prescription to be used in order to insure that a health care professional has thought about and evaluated the use of a medication in an individual. Your best counsel comes from the provider at your local clinics; they can help individualize a medication schedule for each patient. Be aware of medical terrorists who tell you that your medications are dangerous. Disease is dangerous. Medications are designed to help cure and prevent disease. The health care profession is, by no means, perfect in this endeavor, but we are a lot better at it then the medical terrorist would have you believe.