Thursday, September 8, 2011

Medicine and the Media

You cannot watch the network evening news and not be impressed with the pervasive advertisements for prescription medicines.  After an almost incomprehensible rapid fire detailing of cautions about potential adverse side effects, each advertisement ends urging you to ask your doctor if it is the right drug for you. Every year since direct-to-consumer prescription drug advertising was approved by the Food and Drug Administration (FDA) in the mid 1980s, spending by the pharmaceutical industry for such advertising on television and in the print media has increased substantially.  The idea that extraordinarily large sums of money are spent bringing to your attention a product you can get only by convincing an intermediary - your doctor -  to write a prescription is cause for concern.  Think about it.  If you are successful you have to wonder why it took your intervention to get it.  What does your doctor not know that you learned by watching Brian Williams?  You've got to wonder what else your doctor doesn't know!  What about all those threatening warnings?  Does your doctor know about them?  What about the warnings of the interactions with other medicines?  Does your doctor remember what other medications he/she has given you?  What about the ones other doctors prescribed for you?  The next time you are handed a prescription you asked for yourself - contemplate just how much thought went into the decision to give it to you.

It is a wise idea to avoid drugs that have recently been approved by the FDA.  The drug studies that pharmaceutical companies submit to the FDA seeking approval to bring them to market are not designed to detect infrequently occurring, adverse effects.  It is only after a drug is in wide use that most potentially serious and even fatal reactions are revealed.  The following caution appears in every print drug advertisement.   You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit or call 1-800-FDA-1088.

The fact that there is no existing structure for the establishment of the necessary data base to identify serious adverse drug reactions and it's left to physicians and patients to generate the relevant information is frightening.  To put this in perspective, Avandia, a drug for the treatment of diabetes was initially marketed in 1999.  In 2006, it had $2.2 billion in sales.  In 2010, only after repeated warnings of an increase in the risk of heart attack, stroke, congestive heart failure, liver failure, macular edema that seriously affected vision and death in patients taking the drug, did the FDA take action to restrict prescribing this drug.   Some new drugs after their release are found to be so dangerous the FDA requires what is called a black box warning be issued to physicians (referring to the black border around the warning label)  Let me assure you a black box warning really gets your attention.  I have never written a prescription for a drug after such an alarm has been sounded.  Many physicians are reluctant to prescribe drugs that are new to the market just because of the risk of the unknown.  You should be as cautious.  Always ask your doctor about the important details for any medication being prescribed.

This caution extends even more emphatically to medical devices.  Under FDA rules, many devices are approved without extensive testing in patients or without the requirement that the producers track their performance after being put into use.  The current furor over all-metal hip implants - those with metal on metal joint contact  - may be currently found on the front page of your newspaper.  It turns out that although hip implants typically lasted for up to fifteen years, significant problems have been found in a number of patients who had these particular devices surgically implanted. In many patients, there has been fracturing of the metal surfaces of the replacement joint which while apparently not life threatening can cause pain and other debilitating symptoms, resulting in the need to re-operate to remove the implant with all of the attendant risks of surgery.  

Every medicine or medical device has the potential of causing adverse reactions, some of which can be very serious and even life threatening.  Since there is no early warning system in place designed to identify the potential danger of drugs or medical devices and recognizing all the short comings in the processes involved in bringing them to market, to minimize your risks you must ask the right questions and carefully consider the answers you get.  Only in this way can you assess the chances of having to deal with an untoward event.

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