Rand,
One thing that you must realize about the FDA is that in spite of all its efforts, it is always about three measures short of the tune. It apporved Redux, which was later removed from the market for causing heart valve problems and primary pulmonary hypertension. The Fen/Phen formulation caused great problems and is off the market. A drug called Ruzulin for diabetics has caused death by liver failure and is off the market in Europe, but still avalable here. This agency is perpetually obstructive with the wrong drugs and fast with the right ones and has much to learn. Well, that is a little harsh, and I admit it, but in spite of their efforts, they do not protect the public in the way that they would like us to believe.
I wish to tell you of my problem. As a practicing pharmacist, I have great difficulty finding factual information for my patients because all the information is edited. The drug industry has a great function in this. As an example, when a new drug is released, I want to know how it interacts with other drugs on the market. FDA does not require that these tests be done. I do not know how it effects pregnant women or children. These tests are not required. They simply state that they do not know. That not tests have been done.
How do you think that I feel in advising my patients. It is sort of like Russian Roulette, if you know what I mean. We will throw this thing out there and see what happens. (I am being a little harsh here on purpose). Many times, the clinical problems are not known or do not come to light until there is broad distribution and use of the drug.
Individuals respond differently and have unique problems with potent drug products. Many times, the primary physician is perplexed. Rightly so.
This whole health care scenario is an industry in flux. Large, profit oriented interests have taken over. They dictate to the patient and to his physician the therapies and treatments which benefit the company or interest. Patients are told which physician they must see, which distan mail-order pharmacy they must obtain their medicines from, and how many days of medication they may have. If they wish to take a vacation which is longer than their alloted supply of medication, they must beg their insurance/PBM provider to issue an exception.
Very dedicated health care providers are leaving. Community pharmicists are going out of business in droves. We will be left with an uncaring and beuracratic system where we contact our providers by e-mail Monday through tuesday (off on wednesday) Thursday through Friday, and go to the Emergency room on Saturday and Sunday.
Many physicians have an impenetrable voice mail system. The patient and pharmacist call and leave a message which may be responded to in time periods ranging from hours to days.
Well, here I am blowing off at the mouth again.
Best to all!!
Healthcare, Jack |
