Posted on 08/05/2008 6:34:48 AM PDT by fightinJAG
ScienceDaily (Aug. 5, 2008) — Americans are likely to be exposed to unacceptable side effects of FDA-approved drugs such as Vioxx in the future because of fatal flaws in the way new drugs are tested and marketed, according to research to be presented today at the annual meeting of the American Sociological Association (ASA).
"Drug disasters are literally built into the current system of drug testing and approvals in the United States," said Donald Light, the sociologist who authored the study and a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey. "Recent changes in the system have only increased the proportion of new drugs with serious risks."
According to a 1999 report for the Institute of Medicine, adverse drug reactions (ADRs) are the fourth leading cause of death in the United States and more than two million serious reactions occur every year. ADRs can occur for a number of reasons, including improper prescribed dosage, drug abuse and drug interactions.
Light's analysis identifies the organizational foundations of patient risk from prescription drugs and suggests institutional reforms to help avoid or reduce future drug disasters.
According to Light, rather than using current approved drugs as benchmarks of efficacy, the existing testing system evaluates the effectiveness of new drugs based on their effects compared to placebos. Systematic reviews indicate that one in seven new drugs is superior to existing drugs, but two in every seven new drugs result in side effects serious enough for action by the U.S. Food and Drug Administration (FDA), including black box warnings, adverse reaction warnings, or even withdrawal of the drug.
(Excerpt) Read more at sciencedaily.com ...
The more I learn about how the medical research/pharmaceutical industry ignores rigorous application of the concept of “cause and effect” (as opposed to simple correlation), and the more I learn about how drugs are approved (often based on “safety” without any demonstration of “efficacy”), the more I become a medical atheist.
The goal is to have every American on ten pills a day for life. I have a frined who is now on meds...and he’s not better for it.
And life life expectancy and quality of life increase every year. The doom and gloom does not match the facts.
Thank God for dedicated, intelligent medical professionals.
ROFL! Thanks for posting such a fitting term to what my husband and I have been practicing for years.
Too many people we know seem to need a doctor and pill for everything, while we practice a more common sensical approach.
On the other hand, we have another friend who has survived a broken back and several kinds of cancer due to modern medicine, so it ain't ALL bad. :-)
The more I learn about how the medical research/pharmaceutical industry ignores rigorous application of the concept of “cause and effect” (as opposed to simple correlation), and the more I learn about how drugs are approved (often based on “safety” without any demonstration of “efficacy”), the more I become a medical atheist.
The problem starts with the fact that the ability to measure something does not mean you know how to control it or understand it.
There are so many complicated issues that no one entity can handle...
I am not anti-FDA. I agree with you that we have the best system in the world.
However, that is not always enough. There is so much that researchers do not know and, as you said, cannot handle. The Law of Unintended Consequences, which is very real, is massively more complicated when working with the human body.
The problem with measuring effects is not only that the ability to measure something in no way means we understood what was measured, but something more fundamental: how do we even know what to measure?
There are zillions of things going on in the human body that change over time and over individuals.
Here’s an example from a discussion I had with a rheumatologist:
The gist was: the way medicine today measures “inflammation” does give some insight into the body’s inflammatory state. Clearly, however, there are people with “normal” inflammatory markers who clinically are suffering from strong and systemic inflammation. Therefore, the “normal” tests for inflammation are simply not measuring whatever it is is that indicates that individual’s inflammatory level.
We said it was like measuring sugar in a muffin. If you measure sugar by looking for sucrose, you get one number. You may say, “that muffin doesn’t have much sugar in it.” But what if you measured for HFCS, dextrose, glucose, fructose and others? You would get a very different measurement of how much “sugar” was in the muffin.
What if you didn’t know anything other to look for than sucrose? You would think the muffin was low in sugars, when in fact it was not.
The goal of sociologists is to disrupt the established order as much as possible. The goal of those who teach is to produce *change agents*. If they can rope in conservatives, moderates and political independents, as well, then they are truly doing their job. Medicine and ag policy are two areas where they successfully co-opt even those who are not already moonbats.
This is not conspiracy theory, BTW. I know sociology professors who brag that they are creating activists. One, who has managed to get himself elected to a Board position at a club we belong to, has made it his business to harass a disabled veteran who is also a member by utilizing every obscure regulation he can find to use against him and incite others to go along in the name of “obeying the rules”. We know he is doing this simply because the man in question is military and proud of it, since the same rules are ignored by others who agree with the Board member’s politics and there have never been consequences, let alone a breath of criticism.
Read all studies by sociologists with extreme skepticism.
I can't imagine paying much attention to anything that a sociologist might have to say. This would especially apply to what they have to say about drug testing unless they were relating to their own experimental history of recreational drug use.
No, it’s not all bad. However, I am not going to take every pill shoved at me by doctors. I can read and too often I have researched the journals and found, for example, that the blood pressure medicine recommended to me does indeed seem to lower BP, but also does not appear to effect outcomes!
IOW, yes, it lowers BP, but that doesn’t seem to lower the risk of heart disease or stroke.
So with no real evidence that it will actually change outcomes, and real evidence of nasty side effects, I take a pass.
I take one drug that has truly saved my life.
That said, I have been prescribed many that I eventually refused to take because I found no evidence that they would actually help my long-term help, as they were supposed to do.
My point is that I will not go on blind faith in the system.
Especially older people. They just get prescribed one thing after another, then something to counteract the side effects of the other stuff they were prescribed. And usually I see them get so nervous and down, with all that medication becoming a source of worry to them.
Sometimes I think going to the doctor a lot causes a lot more stress and worry than it’s worth.
“Thank God for dedicated, intelligent medical professionals. “
Who are few and far between.
Tell me about it! I worked at an E.R. where over seven hundred Dr.s sent patients. Did I ever get an eyeful of incompetence, arrogance, outright medical butchery, and malpractice!
I gave it up after seven years, and let me tell you! Percentage wise, less than 5% were worth their salt! The rest should have found another "Art" to pursue! Sickens me to this day what I observed!
BTW, the RN's that worked there were the true Heros of the Medical Profession!
Not sure what they are fretting over. By the time the democrats destroy America’s oil industry, there will be few drugs available or affordable anyway, since most of them are made from petroleum products.
(eye roll)
Well, the longer you live, the more chances you have of dying of something. So, longer life = greater risk of death.
Or something like that.
“BTW, the RN’s that worked there were the true Heros of the Medical Profession!”
They usually are.
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