Last year, my 80-year-old mother underwent knee replacement surgery. She was in otherwise good health, and decided to have the surgery to improve the quality of her life. The old knee had made walking difficult, and her doctor assured her that a replacement would give her back the ability to walk and exercise with much less pain and effort.
The surgery was successful, and after a few days in the hospital, she was released to a rehabilitation center where she was to stay for a week to receive some therapy. She is a determined woman and wanted to get back on her feet, literally.
But things didn't quite go as planned. A few days into her stay, she began complaining of pain in the knee and noticed some swelling. Medical personnel assured her that this was normal, but as the swelling and pain increased, she knew instinctively that something was wrong.
Finally, a doctor was called in to look at her knee and realized that this swelling was not routine. She was rushed back to the hospital where doctors confirmed that she had developed a blood clot, which had it dislodged, would have most likely had dire effects, and might even have killed her.
She was confined to bed rest, given blood thinners and her recovery was set back two weeks. Once she was released, she had to endure more therapy but the knee had already set up and even now, a year later, she is still not able to use it normally.
Why did this happen? The doctors had no answers, but when her history was studied, they determined that it may have been due to her participating in a drug trial several years prior. She had been in a test group for Vioxx, but never learned whether she had been given the drug or a placebo. Those records weren't available but, considering what has been learned about this drug since, it is not a stretch to think that this was the case.
How many people participate in trials without knowing the drug that they were given? If those people ultimately suffer side effects, do they have any recourse? This is an area that has received little publicity but certainly opens up a new area of discussion. At the least, potential subjects might want to think twice before taking part in such a study.
It is understandable that patients might want to be part of a study. Arthritis sufferers will go to any lengths to find relief, even if for a short time. And certainly, these drugs are effective. But at what cost?
My mother has had to give up taking any kind of arthritis pain medication for over a year and continues to take blood thinners to prevent clots. She can't even go to the dentist for fear of bleeding. This vital woman who thought she was going to be improving the quality of her life is now angry and discouraged, and still in pain. There is no recourse, but she hopes that her experience can alert others to at least ask the hard questions when participating in these trials. Understandably, she is reluctant to have the other knee done and is willing to live with the pain rather than risk death.
In an age where people are suing for being injured by coffee that is too hot, one wonders how these companies protect themselves from litigation during these trials. Participants sign lots of forms, acknowledging their risk and signing away their rights to sue. But, for a daughter who loves her mother, no amount of money could have compensated for the loss of her mother, if the worst had happened. Thankfully, she survived this. But how many do not, and is it worth it?
