Much is made of the fact that pharmaceuticals are tested before being released. Trials are done to assess whether the drugs work and to assess the side effect profile. Many drugs never make it to market because in the trial process either they are not found to so much or there are significant other problems, which outweigh their benefit.
This process is a useful one. However it also has limitations. Over the last few weeks we have seen data emerge about long term unexpected problems with widely used drugs. Statins and proton pump inhibitors are in the top five for widely used drugs in many western countries. They are also amongst the most costly to the health system. Statins are used to “treat” cholesterol and proton pump inhibitors are used for ulcers reflux and other stomach acidity problems.
When trials are done they are conducted on relatively small numbers of patients for a relatively short period of time. At tops it may be a few thousand people and often for less than two years. Indeed it may be so many hundred people for so many months. It should not come a s a surprise then that less common problems or those which may take many years to show up will not be picked up in these trials.
When the drugs are used by millions of people for many years new problems may emerge. For example an effect, which occurs one in every 100,000 people, may not be seen in a trial of 5000 but there may be 20 by the time 2 million people have used it. Of course effects, which take ten years to show up, will not be seen for at least that time.
So after nearly 20 years of statin use we are seeing that there are increased rates of liver dysfunction kidney failure, cataracts and myopathy (muscle damage) in those taking long-term statins. The increase may be as high as eight fold. These figures come from studying 2 million people over a six year period. The findings were published in the British Medical Journal.
Meanwhile the FDA has called for labeling changes on proton pump inhibitors after finding an increased rate of fractures in people using them long term. It has also been found that long-term users have much higher rates of clostridium difficile infection causing diarrhea.
It is not surprising to me that when you interfere with the gut there will be consequences. The stomach has acid for a reason. Block it and you will affect absorption of food and other gut functions. The higher rates of diarrhea suggest that the bacteria are better able to survive in a less acidic stomach. Bone fractures suggest the absorption of minerals is being affected. There may be other direct effects on bones too, which have not been determined.
Does this make these drugs dangerous? No it does not. What it shows is that long term use of medications have unexpected consequences. In also shows we do not always know the long term safety of drugs when they are released.
Most importantly it tells us that reliance on drugs for lifestyle related conditions is not a free lunch. The notion that it is easier to take a pill than to change our eating patterns (for example) may seem fine in the early days. After the unexpected long term problems arise it may not seem like as good an idea.
The bottom line is that lifestyle related conditions require lifestyle solutions. Some people may need medication but this should be used for as few people as possible and for the shortest possible time.