Just a few hundred years ago, there was very little real medical science. It was little better than voodoo, combining observed reactions to natural substances as drugs with some crude surgical skills. We have come a long way except. . . Except developing new drugs is still all trial and error. We have the technology to create hundred of new molecules, but we do so without any real idea of what these new combinations might actually do. The majority prove inert. Some are poisonous and the rest. . . Well the rest do things to the body. We often have no idea how these drugs are producing the observed results, but everyone agrees they do produce those results consistently. So it’s left up to the FDA to decide whether these magic formulae are safe enough to be sold into the market. This is where the guesswork comes in.
In the current system, the FDA does not run the trials. Indeed, there’s no attempt to produce any independent tests for a new drug. It’s left to the manufacturer that has invested tens of millions of dollars in research to prove the drug safe. Not surprisingly, with so much money on the line, the majority of trials run by the manufacturers find the drugs effective and safe. And, until recently, the FDA just bowed down and issued a license. Since President Obama came into the White House, the FDA has shown a little more backbone but, in many cases, this is too little too late.
As an example of the problems, let’s look at the safety of nonsteroidal anti-inflammatory drugs (NSAIDs). Not so long ago, the FDA finally decided that Vioxx and the other Cox II drugs were directly responsible for damage to the heart valves. In turn, this led to a significant increase in the risk of strokes and heart attacks. It then occurred to the medical profession to wonder if other painkillers had a similar effect. The medical evidence on NSAIDs is interesting. In 2002, a study discovered that 40% of adults taking an NSAID over time for osteoarthritis had unusually high blood pressure. They are also known to aggravate ulcers and increase the risk of bleeding into the intestines. There are now vague discussions on whether all the more powerful of the NSAIDs should go through further tests to decide whether they raise the risk of heart disease.
Faced with this recognition that our understanding of the risks is poor, the manufacturers have wheeled out the usual reassuring PR messages. Millions of people around the world have been taking these drugs and there do not seem to be problems. It remains to be seen whether this complacency will be challenged. In the meantime, there is one reassuring beacon of hope. Although there is no doubt that some of the NSAIDs may be putting older people at risk if they take the drugs over long periods of time, Ultram remains untouched by the speculation. As a synthetic opioid, there seem to be few risks affecting the cardiovascular system. The message is therefore clear. If you have a chronic problem, be careful in your choice of NSAIDs. But be confident that if the pain is moderate to serious, Ultram will not put your heart at risk.