Posts Tagged ‘ Adverse Side Effects ’

It’s always sad when a great story fails to stand up to the historians. We all like Longfellow’s version of the ride but, it seems, he was only one of many and never uttered the now famous warning about the Brits. Unfortunately, the modern warning will stand up to the test of history. It’s a matter of fact that there was a Boom in births between 1946 and 1964. Worse, it’s also a matter of fact that the so-called Hippie generation is more heavily into street drugs like marijuana and the legal highs of prescription drugs than any other group in the US. Ask anyone connected to the federal Substance Abuse Administration and they will tell you the same story. The number of people aged 50 and more who abuse drugs is rising fast. Why should this matter? Well, the healthcare service includes drug-treatment programs that are supposed to help people through the pain of withdrawal and to teach coping strategies for life after dependence. As the population ages, a wave of people who have consistently used a significant range of different substances is going to begin encountering health problems. You cannot abuse these substances indefinitely and avoid the adverse physical consequences. The expectation is that the treatment programs will collapse unless, at a minimum, the number of treatment facilities doubles over the next five to ten years. Worse, the older people are, the more expensive it is to treat them.

What is the main health problem going to be? As bodies age, everything slows down. In particular, the liver and kidney lose efficiency and do not clear drugs from the blood stream as quickly. If older people are also starting up new treatments, say for high blood pressure, the drugs could interact and cause major adverse side effects. There could also be problems for physicians as they try to diagnose diseases and disorders. For example, there is clear evidence that the long-term use of marijuana causes some memory loss. How is this to be distinguished from the memory problems stemming from the early onset of Alzheimer’s? At present, there is no clear evidence as to how often physicians ask their patients about substance abuse. Just as important, there is no evidence about how honestly patients answer questions about their sometimes illegal drug use. It is obvious to the federal government that there should be routine screening of all patients aged 50 or more. This would cover the spectrum of substance abuse from alcohol and nicotine to painkillers. All patients should be counselled on the need to quit. But patients may fear admissions of illegal drug use may end up on their records. At the least, this will damage their reputation, but it could result in prosecution.

In terms of prescription drugs, the most often abused are the anti-anxiety and treatments for insomnia, mainly ambien. There is a reflex in physicians when their older patients report problems in sleeping. This is an expected aspect of growing old. People lose their jobs. They start feeling socially useless. This leads to stress and some depression which interferes with normal sleep patterns. Only a few physicians are trained in geriatrics. They neglect to ask about lifestyles and just write the standard prescription for ambien. While none of this changes the facts about ambien which remains the best of the drugs to treat insomnia. It should alert all Boomers about the need to review lifestyle with their physicians and, if possible, cut down or quit nonessential drug use.

This takes us back a few years to a time when stories began to surface about adverse side effects to the use of drugs used to treat erectile dysfunction. Men had begun to report changes to their eyesight. One or two men apparently lost their sight for short periods of time. On many occasions when side effects are reported under the Postmarketing Surveillance Program, the FDA does not react immediately. Sometimes, it does not react at all. Without going into the politics of its role, some critics suggest the FDA is in the pocket of the pharmaceutical industry and would never react to reports of side effects unless the evidence is too public and overwhelming to ignore. That’s what made it all the more surprising when the FDA decided to apply a watered down version of the precautionary principle to erectile dysfunction drugs. Just so we all understand, the precautionary principle says you pull a product off the market until it is proved safe. Since proving the negative is difficult, this can mean the product is off the market for a long time. With erectile dysfunction drugs, we are talking about retail sales in excess of one billion dollars in 2008. You do not mess with this market by shutting it down. The most you can do is change the label to warn users of potential dangers.

In July, 2005, the FDA issued a notice acknowledging rare reports of eye problems. The notice did not accept there was evidence of a link between the drugs and the vision problems. It simply advised men affected to seek emergency aid if the rare event affected them. From a scientific point of view, there is a strong likelihood of a link. These drugs target PDE5 in the body. The relevant arteries in the eye are controlled by PDE6. The drug may not be completely specific in all bodies and the effect on PDE5 may shade into PDE6. That said, the pharmaceutical industry had a marketing problem. Even though everyone acknowledged these were extraordinarily rare events, the release of the notice by the FDA did cause some alarm. The industry therefore commissioned some research which was published this year in the Archives of Ophthalmology. It’s good news. Some 250 men men with good eyesight and erectile dysfunction were recruited and given various dosages of the drugs, one pill per day for six months. Their vision was routinely monitored throughout the trial period. There were no significant differences found between their sight before and after the period. There was no measurable effect of any kind in any of the men (except their erections, of course).

One word of caution. To be able to generalize from one sample to the population at large, there should be more men included in the trial. Only 250 men is not statistically significant. That said, this is a detailed study and the results are encouraging. Viagra has not been given an absolutely clean bill of health, but this comes close. If the industry can be persuaded to recruit a sufficient number for the next trial, we can arrive at a definitive result. While we wait, buy viagra with (almost) complete confidence. There is no evidence anyone has ever lost their sight because of this drug.