Patient Safety
by Paula Martinez
Instead of asking is a drug safe we should ask about patient safety. The reason being is the drugs that the FDA approved without long enough trial periods are on the market. So now the drugs are being sold as safe and the patients may not be. The pharmaceuticals company usually insists the drug is completely safe. Are we safe from the drug company that is the question?
In the newest tale the blockbuster diabetes drug Avandia seems to
play a role in causing heart problems. Avandia is used to control the blood sugar for Type 2 diabetes. The side effects range from a blister to sudden cardiac death. Avandia's label warns about possible heart failure and other heart problems when taken with insulin. The drug also raised LDL, or bad cholesterol, and can cause fluid retention and weight gain. This drug has been on the market for eight years before doctors were aware of the drug's possible role in their patients' heart problems. In January there was a total of only 50 adverse events reports and in February only 73. Only is the operative word that gets my dander up. From April 16 to May 21, when a study was published that revealed possible heart risks from the drug 121 events were reported, including 11 deaths. In the 35 days after the study 357 events were reported, including 38 deaths. What is the record for the whole eight years?
The medical community and some members of congress are asking is the FDA properly investigating safety issues. The FDA issued an alert only after the May 21st study came out even though Glaxo had informed the agency of its analysis of heart risks a year before and possibly in 2005. Who's looking out for the patient?
Dr. David Graham an FDA dug safety "expert" said "you really can't infer anything about incidence rates from that" because the spike in reports of adverse effects are likely due to "publicity effect" of the study. This is a very well- known phenomenon said company spokesperson Mary Anne Rhyne. Wow what a relief that patient safety if everyone's number one concern.
Patient safety is something that you can not assume is the first thing on the agenda of ether the FDA or Pharmaceuticals Company. There are always flaws in studies and interpretation of data. Doctors can miss problems with a drug because they do not connect their patient's heart problem with the drug they are taking. Reporting a drug's side effect is voluntary and the doctors are not legally required to do so.
This is not a matter of discontinue all medications immediately. It is clearly an indication that patient safety should be the number one concern of the patients. The one thing that is imperative is that people learn what they can do to lessen their reliance of pharmaceuticals. It is really a learning process that requires a desire to minimize your dependence on drugs.
Most conditions are diet related. The safest way to help yourself is to remember your health is a product of your lifestyle. All the chronic health conditions are on the rise as our waistlines expand. Patient safety is in lifestyle changes, not in new drugs.
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