An internal medicine doctor recently told me her advice to patients was that it is o.k. to take vitamins and minerals, but she never recommended herbals because they were not studied. “We have to practice studied medicine in order to make the best recommendations for our patients”, she said.
I think most people agree the best way to practice medicine would be to make recommendations based upon benefits proven in the studies. The problem is this notion of practicing “studied medicine” is a fairy tale believed by both those practicing medicine and by those receiving medical care. The belief that doctors practice “studied medicine” is on par with believing in the Tooth Fairy. My apologies to anyone crushed by the realization that the disappearing canine from under their pillow was not funded by Tinker Bell’s cousin.
I know…I know…this claim goes against just about everything that has been drilled into our heads since we were young. You need to trust your doctor because they are basing their recommendations on FDA approved therapies. And, the FDA only approves therapies that undergo rigorous study. Thus, doctors obviously practice studied medicine. Let me shed some light on this subject so we can all click our Ruby Slippers together to get ourselves out of the Land of Oz. It is important for you to realize that doctors DO NOT practice studied medicine!
One of the facts giving comfort for the use of prescription drugs is they have to endure a rigorous process of study in order to gain FDA approval. There are three major problems with allowing yourself to become comfortable with this process. First, the FDA approval of drugs does not mean the drug is safe. Secondly, doctors routinely utilize drugs in a manner that does not have FDA approval. Thirdly, many drugs are approved by the FDA even though they show very little clinical benefit for the patient. Let me give you a couple of examples. I could give you dozens, but I am way too lazy to type all of that information. The examples I am about to use are not unique by any manner.
A class of anti-inflammatory pharmaceuticals, known as selective COX-2 inhibitors, had three main drugs approved for prescription use by the FDA. These drugs include Celebrex, Vioxx and Bextra. There is just one slight problem with the use of these drugs: THEY KILL PEOPLE! But, of course, you have been led to believe the FDA protects us from this possibility. Unfortunately, you are sadly mistaken.
Most of you may know that Vioxx and Bextra were “voluntarily” removed from the market due to the fact that they significantly increase, in part, the risks of stroke and heart attack. In fact, some estimates are that 50,000 people have had their lived destroyed by these drugs. Now here are some interesting and disturbing facts.
I began warning patients about the dangers of COX-2 drugs about one full year prior to Vioxx and Bextra being taken off the market. How did I know this? I read the alarming studies that strongly suggested these drugs were dangerous. Many doctors, who only practice studied medicine, ridiculed my position and cautioned their patients about getting their information from a quack. One even told me I should leave the practice of medicine up to medical doctors. He obviously thought his M.D. degree stood for Medical Deity! I cannot even express to you how much I dislike people who think the world of themselves.
So, did the FDA take these drugs off of the market? The answer is no. The FDA basically told the companies making these drugs that they could voluntarily take their drugs off of the market to save face or have the FDA most likely recommend they be removed. Thus, the companies “volunteered” to take their drug off of the market.
Some of you may be wondering why I would be using this as an example of how FDA approval doesn’t assure safety. Didn’t the fact that the FDA forced these drugs from the market prove their effectiveness at looking after the well-being of the population? Not by a long shot! Did you notice there were three drugs in the selective COX-2 class? Celebrex is still on the market. So, the FDA must have studies showing that Celebrex is safe and does not cause an increase in heart attacks or strokes, right? WRONG!! Celebrex does increase the risk for heart attacks and strokes, but the FDA “believes” at a lesser, more acceptable level. Here is the statement made by the FDA, “We have concluded that the benefits of Celebrex outweigh the potential risks in properly selected and informed patients.”
Let me translate for you: “We have concluded the benefits of reducing pain gained from taking Celebrex outweighs the fact that it also kills a significant, but unknown, number of patients each year. Thus, we suggest that this drug only be given to a properly selected and informed group of patients.” Now, let me ask you two very important questions that will illustrate just how absurd the FDA’s position is on this matter. How do doctors determine which patients will not suffer an adverse event from taking Celebrex and is anyone fully informed about the risks when they are give a prescription for this drug? The answers to these questions are that doctors have NO WAY of determining who will get a heart attack or stroke from Celebrex and the only doctor who goes over the risks of taking a drug with a patient is the one you see on television pharmaceutical advertisements. When was the last time your doctor wrote you a prescription and then explained to you all of the potential serious side effects?
Let’s shoot straight here. If the FDA’s true concern was with protecting the consumer they would have taken all of the COX-2 drugs off of the market as soon as there was an indication of danger and would not have allowed their return until studies could be done to prove their safety. Unfortunately for the makers of these drugs these studies would take many years to complete and this course of action would have been financially devastating for them. What is going on here? The FDA is more concerned with the financial viability of the pharmaceutical industry than with your safety. To come to any other conclusion requires a complete disregard for the facts.
Nexium, made by AstraZeneca, is among the class of drugs known as Proton Pump Inhibitors (PPI’s). This class of drugs is among the most prescribed in medicine today. The FDA approval for Nexium is for 4-8 weeks of use. The longest recommendation for use is 6 months and only for the maintenance of the healing of Erosive Esophagitis and for the risk reduction of NSAID-associated gastric ulcers. Here is a quote from a document produced by AstraZeneca and found on FDA.gov, “Controlled studies (for Nexium) do not extend beyond 6 months.”
Thus, if doctors practiced “studied medicine” they would only allow most of their patients to use Proton Pump Inhibitors, like Nexium, for up to 8 weeks and a few patients to use these drugs for at the most 6 months. Almost ALL doctors continue to prescribe this class of drugs to their patients for years! My brother-in-law’s brother (I know…slightly confusing) was told by his G.I. specialist that he had people on PPI’s for a decade and had no reservations in doing so. Recent studies show that long-term PPI use significantly increases risks for osteoporosis bone fractures, pneumonia and chronic diarrhea.
How many people taking these drugs do you think got letters or calls from their doctor telling them that since they only practice studied medicine their recommendation was for them to stop using their PPI medication after 8 weeks? The answer is NONE OF THEM received this type of letter! I wonder if that G.I. specialist has sent letters of apology to his patients for not practicing studied medicine and causing them to have an increased risk for bone fractures, pneumonia and/or chronic diarrhea? What do you think?
I always find it comical when people use FDA approval (or lack of FDA approval) as their gauge to determine their comfort level for taking any drug or supplement. I hear people say “that is not FDA approved” all of the time. The only thing you can be confident of is that FDA approval means the substance will most likely not act like a poison and kill you in short order. If you think FDA approval guarantees safety or that doctors will use FDA approved drugs along the approved guidelines…welcome to the Land of Oz.
How many people do you know who take more than one prescription at a time? My record is a patient who was taking 21 different prescriptions! Although that is not common, it is extremely common for me to see patients taking between 3 and 6 different drugs at the same time. The fact that doctors mix prescriptions without any reservations is the reason why I almost choked up a hair-ball when the internal medicine doctor told me that we should not recommend herbals due to the lack of studied support for their use. The hypocrisy of this statement was so evident I was forced to think about how this doctor could even make such a statement with a straight face.
Remember, the claim is that doctors have to practice studied medicine. I would like you to show me even ONE study proving the long-term safety of using 2, 3, 4, 5, 6, or more drugs together. There are NONE! So, I ask you to explain to me how anyone can engage in the practice of studied medicine without having even one study to support the use of giving patients multiple prescriptions at one time. Can you imagine a doctor telling you to never take an herb due to the lack of studied support, but then writing you prescriptions for 3 different drugs? How hypocritical!
I would totally understand the practice of prescribing many drugs without regard to safety if it was well known that drugs do not interact with each other. Unfortunately, we know that drugs do indeed interact with each other. Just look at the insert for any prescription and see the list of other drugs you should not use when taking that drug. If you think this is an exhaustive list of any and all potential reactions you are hopelessly naïve. The FDA finds new reactions all of the time and to think there are no more to be discovered is ludicrous. For example, the FDA has recently announced that Prilosec (the cousin to Nexium) blocks the benefits of taking the blood thinner Plavix. There are many thousands of others to be discovered.
The Bottom Line
The reason why we like the thought of hiding behind the smoke and mirrors of following the recommendations of “studied medicine” is because it gives us a false sense of security. It gives us a buffer of assurance in protection against being fooled by false or misrepresented claims for any health product. All of us hate being played for the fool! None of us likes to be taken. What each and every one of us needs to understand is that there is a stark difference between having a study suggest the benefit for a substance verses practicing studied medicine.
Doctors use the FDA approval process to create the deception of practicing studied medicine. The hypocrisy of this claim is well illustrated by the examples I use in this article. As I see it, there can only be three reasons to explain this hypocrisy. The first is that doctors are simply unintelligent and do not have the capacity to understand the hypocrisy. There is no way this can be true. The second is that doctors, as a whole, are disingenuous and are knowingly deceiving patients to protect their way of practicing medicine. This may be true for a few doctors, but there is no way this can apply to the majority of health care practitioners. The final possible explanation is that doctors, as a whole, are intellectually lazy and have not put forth the effort to recognize the hypocrisy of their claim of only practicing studied medicine. Shame on them!
For your sake, I hope you start to question your doctor each and every time they write you a prescription. Stop thinking about your doctors as Medical Deities and remember that they are “practicing” medicine. It is important for you to realize that you are the one on whom they are practicing! My hope is that you will reject the all to commonly used argument that herbals are potentially dangerous because they are not studied or FDA approved. Most natural products are NOT FDA approved, but they are indeed well studied.