Pharmaceuticals companies have shifted their marketing and research and development money to medication that are mass marketed for non essential, or non lethal conditions. The problem is, some of these medications might pose serious risks or have severe side effects when they are prescribed for conditions that are for the most part considered non lethal or just part of the normal aging process.
With age, testosterone levels diminish, but they do not necessarily lead to any diminished level of well being, or pose any detrimental consequence to the body. The mass marketing campaign to justify the prescription of testosterone, a substance that is banned for use without a prescription to the population at large, is a result of the creation of a new niche market. The suggestion created by the marketing campaign appeals to those men who feel as if the aging process is changing their lifestyle and well being and that such a process is not 'natural' but a result of some malfunctioning physical process. A lot of it is also associated with the implied benefit of the medication affording the patient a greater sex drive.
However, the mass use of testosterone is now bringing to light the dangers of using such medications in instances when it is not warranted or needed to restore the person's health. In fact, many of the risks that are associated with steroid abuse, is now becoming apparent in the use of prescribed testosterone supplements.
Reports of heart attacks, strokes and deaths, are now raising the concern of the FDA, which has promised to review the use of such medications for possible risks. The result of independent research has already yielded stark results: users of testosterone supplements can face double the risk of heart attacks, even for those people who do not have any known heart conditions or conditions that can lead to heart disease. And that is where the crux of the problem is.
The effect of testosterone, or steroid use, is well documented. Why then did the FDA allow such mass marketing and prescription of testosterone supplement in a such a sweeping fashion and with little regard to the underlying risks or condition of the patient?
In fact, some people have died from taking the medication. The pharmaceutical company defends the product by saying that those people who have suffered heart attacks or died had underlying conditions, such as cardiovascular disease of diabetes, which placed them at greater risk for a heart attack.
But it begs credulity that such medications, now obviously in the medical mainstream, are doled out to patients with noted and clear history of underlying cv conditions or other risk factors. And to boot, the study has highlighted the fact that the risk is real even for those who do not have known heart conditions.
This writer, for example, has first hand knowledge of just such a medication, in this case topical, prescribed to a man with severe cardiovascular problems. Fortunately, the patient did not take the medication as prescribed, and a month later, was in the hospital for cathererization. The patient in this case had severe arterial occlusion, and was in such a poor condition that a bypass was not offered as a possibility. The doctor who prescribed the medication furthermore, is a family doctor who should have been aware of the patient's medical condition.
Apparently this scenario might be a too frequent reality.
The study also outlined how for men over 65 who did not have a history of heart disease, but might have undiagnosed issues, the risk of a heart attack tripled in the 90 days of taking testosterone supplementation.
This latest study is not the first one of its kind. It is actually the fourth study that points to the risks of testosterone supplementation. It then raises the question as to why the FDA's response was so long in coming.
The prescription of testosterone supplements has skyrocketed since the pharmaceutical companies' wide ranging marketing campaign began a few years ago. Numbers tallied so far show that the prescription of the drug has multiplied fivefold.
The problem comes from the advertising campaign, which aggressively pursues men with the promise of greater vitality and sex drive. More insidiously, the advertising campaign depicts men who are feeling sluggish or with low levels of energy as possible candidates for the medication. Considering that such symptoms are part and parcel of the aging process and do not take into account the diminished penchant for exercising and fitness in men, the advertising campaign in effect, is playing on the sentiments of all men who have reached middle age and any men who feels his sex drive to be inadequate.
What is worse, recent trends show that younger men are now the fastest growth sector for testosterone supplementation.
What is more appalling, is that the study recommends that doctors include discussion of cardiovascular issues with patients, leading one to believe that such discussions rarely ensue. This kind of medical levity is reprehensible, but it might also have to do with the pharmaceutical companies' lack of emphasis to the medical community that they should do so.
Either way, the study suggests that a large trial be conducted to see which men should and should not be prescribed the supplementation to further ascertain its validity as a therapy and more importantly its risks. However, a clinical trial should have preceded the wide ranging prescription of the testosterone medication to begin with.
In an announcement released on January 31 of this year, the FDA outlines its own evaluation of the risk of stroke, heart attack and death associated with testosterone prescription.
In the announcement a particular paragraph stands out: "None of the FDA approved testosterone products are approved for use in men with low levels who lack an associated medical condition". In other words, it was only approved for use in known and specific medical conditions which lead to serious testosterone deficiency that constitute a particular condition or disease.
This particular disclaimer is - in a nutshell - what is wrong with modern day prescription medication process and policy. Because the testosterone supplements had passed the FDA process and was approved, albeit for specific needs and conditions, the pharmaceutical companies opened its use for non specific conditions, and in so doing skirted the process of a trial for use of the medication for needs not specified in the original clinical trials.
As always, which modern medicines, it's caveat emptor.
Op-Ed
Partial source: LATimes/FDA.gov/ 2.20.14
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