Yesterday's post was sidelined by computer problems.
Today I'm up an running on a laptop and surfing the web for more imponderables. Today's question - is the benefit really worth the risk?
Apparently the FDA has approved another new diabetes drug called Victoza despite some evidence that the drug may cause a rare form of thyroid cancer. {The Victoza website includes the cancer warning as the first line under Important Safety Information}.
I'm sorry, but I just don't get why someone would feel the risk of getting cancer is better than trying some other drug to control diabetes. The instance of cancer may be small [and so far seems only to have occurred in laboratory rats], but nevertheless, why should a patient accept the prospect of a debilitiating [at best] and deadly [at worst] disease in order to fight another debilitating and often deadly disease? What really is the trade off?
Sure it's fine if you're not one of the unlucky few to develop cancer as a side effect of your treatment, but what if you are? Then was the risk worth it?
I think the real issue here is, the cost of defending the pharmaceutical company against lawsuits should someone develop cancer as a result of taking the drug, is minimal compared to the profit the company will make by selling the drug and having their reps convince doctors the drug is safe and effective in most cases.
Let's call a spade a spade here. The financial benefit outweighs the financial risk and the cost of human life has nothing to do with the equation.
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Wednesday, March 17, 2010
Friday, February 26, 2010
Consumer Confidence Takes a Hit
I’ve been reading a lot about prescription drugs and drug companies and the more I read, the more concerned I get.
I came across this New York Times article about the dangers of a diabetes drug called Avandia. Apparently Avandia users have an increased risk of heart attacks and heart failure, but the manufacturer of the drug isn’t quite sure they want to take it off the market.
What’s interesting about this is the FDA tends to concur that a dangerous drug should remain on the market. Their solution is to order the drug manufacturer to conduct a study to find out whether Avandia really does increase the risk of heart problems in diabetic patients.
Now, is it just me, or can you figure out what the results of that study are going to be? I don’t need to be psychic to predict that the drug company will conduct the study and find there is ‘no statistically significant risk’ of heart disease.
I propose what we need in this country is an independent drug study team – one that receives no compensation from the sale of drugs and one that is not affiliated with any agency that receives compensation from pharmaceutical companies. They should conduct unbiased drug studies and publish the results.
Then maybe patients would be safe from deadly side effects...or maybe there would just end up being no drugs at all on the market.
Update: There is an article on this in my local newspaper 2/21/10 which states the FDA estimates 83,000 heart attacks were caused by Avandia. Even with this knowledge in hand, the FDA apparently only required the manufacturer [Glaxo/Smith/Kline] to include a warning on the package stating that the risk of heart attack might be increased.
It makes one wonder how many other drugs are doing more harm than good, but the pharmaceutical companies manufacturing them just having been called out on the problems yet or worse, are just being told by the FDA to put mild warnings on the packages. Again, we’re back to how the industry seems to be training people to accept deadly side effects a natural risk involved in treating an illness. Is it really a reasonable trade off – diabetes or a heart attack?
I don’t think so. How about you?
I came across this New York Times article about the dangers of a diabetes drug called Avandia. Apparently Avandia users have an increased risk of heart attacks and heart failure, but the manufacturer of the drug isn’t quite sure they want to take it off the market.
What’s interesting about this is the FDA tends to concur that a dangerous drug should remain on the market. Their solution is to order the drug manufacturer to conduct a study to find out whether Avandia really does increase the risk of heart problems in diabetic patients.
Now, is it just me, or can you figure out what the results of that study are going to be? I don’t need to be psychic to predict that the drug company will conduct the study and find there is ‘no statistically significant risk’ of heart disease.
I propose what we need in this country is an independent drug study team – one that receives no compensation from the sale of drugs and one that is not affiliated with any agency that receives compensation from pharmaceutical companies. They should conduct unbiased drug studies and publish the results.
Then maybe patients would be safe from deadly side effects...or maybe there would just end up being no drugs at all on the market.
Update: There is an article on this in my local newspaper 2/21/10 which states the FDA estimates 83,000 heart attacks were caused by Avandia. Even with this knowledge in hand, the FDA apparently only required the manufacturer [Glaxo/Smith/Kline] to include a warning on the package stating that the risk of heart attack might be increased.
It makes one wonder how many other drugs are doing more harm than good, but the pharmaceutical companies manufacturing them just having been called out on the problems yet or worse, are just being told by the FDA to put mild warnings on the packages. Again, we’re back to how the industry seems to be training people to accept deadly side effects a natural risk involved in treating an illness. Is it really a reasonable trade off – diabetes or a heart attack?
I don’t think so. How about you?
Tuesday, January 12, 2010
Who's afraid of the FDA?
I am now. I wasn’t before I read this book:
FDA: Failure, Deception, Abuse
Compiled from articles in Life Extension Magazine* and largely written by William Faloon.
Forget Salem’s Lot or A Haunting in Connecticut. This stuff is much more terrifying. The book discusses various cases in which the Food and Drug Administration is [and sometimes by its own admission] failing in its mission to protect the health and welfare of the American people.
The articles highlight instances where the FDA guidelines have allowed bad drugs to come to market despite numerous deaths, terrible side effects and poorly constructed clinical trials while oftentimes useful drugs or supplements are stonewalled or denied to needy patients.
I spend a lot of time reading the labels in the health food/vitamin aisle at the supermarket and I’ve always been concerned about those little taglines you see that say in effect: These statements have not been verified by the FDA. It’s sort of a backhanded warning for consumers. It’s not saying the bottle of supplements or the diet drink you’re thinking of buying is bad for you, it’s just saying the government agency established to safeguard your health by testing and controlling the manufacture of anything you want to put in your body hasn’t bothered to find out if this particular product does what it claims to do.
Not a glowing testimonial. Cleverly designed to make you wonder, is this stuff okay? If it’s not, why do they sell it at the supermarket? If it is, why did my doctor tell me it was all hogwash to take supplements? Am I wasting my money or endangering my health?
The book tends to lean toward the explanation that the FDA is under the control of Big Pharma. Drugs produced by companies that have the time and money to wade through all the FDA regulations to get official approval are better, safer, more effective. Supplements that may help you avoid the need for costly pharmaceuticals are not regulated, they don’t undergo the vigorous testing prescription drugs do and therefore should be avoided.
Let’s spin this another way: If it’s cheap and effective, maybe the FDA would prefer you didn’t trust it.
Consider this, “The FDA does not make drugs or directly test drugs to determine if they are safe and effective. The FDA’s role is to oversee the research conducted by pharmaceutical companies…” The results of the trials are obtained by the pharmaceutical company and given to the FDA.
Does this mean the prescriptions in your medicine cabinet don’t work? No…but it does mean they work only as well as the people who make them say they do.
Do you trust the FDA stamp of approval? I used to. Now I’m not so sure.
* Just a note on the other side of the argument. The Life Extension Foundation, authors of Life Extension Magazine, sells vitamins and supplements. Could their reports about the FDA be biased?
FDA: Failure, Deception, Abuse
Compiled from articles in Life Extension Magazine* and largely written by William Faloon.
Forget Salem’s Lot or A Haunting in Connecticut. This stuff is much more terrifying. The book discusses various cases in which the Food and Drug Administration is [and sometimes by its own admission] failing in its mission to protect the health and welfare of the American people.
The articles highlight instances where the FDA guidelines have allowed bad drugs to come to market despite numerous deaths, terrible side effects and poorly constructed clinical trials while oftentimes useful drugs or supplements are stonewalled or denied to needy patients.
I spend a lot of time reading the labels in the health food/vitamin aisle at the supermarket and I’ve always been concerned about those little taglines you see that say in effect: These statements have not been verified by the FDA. It’s sort of a backhanded warning for consumers. It’s not saying the bottle of supplements or the diet drink you’re thinking of buying is bad for you, it’s just saying the government agency established to safeguard your health by testing and controlling the manufacture of anything you want to put in your body hasn’t bothered to find out if this particular product does what it claims to do.
Not a glowing testimonial. Cleverly designed to make you wonder, is this stuff okay? If it’s not, why do they sell it at the supermarket? If it is, why did my doctor tell me it was all hogwash to take supplements? Am I wasting my money or endangering my health?
The book tends to lean toward the explanation that the FDA is under the control of Big Pharma. Drugs produced by companies that have the time and money to wade through all the FDA regulations to get official approval are better, safer, more effective. Supplements that may help you avoid the need for costly pharmaceuticals are not regulated, they don’t undergo the vigorous testing prescription drugs do and therefore should be avoided.
Let’s spin this another way: If it’s cheap and effective, maybe the FDA would prefer you didn’t trust it.
Consider this, “The FDA does not make drugs or directly test drugs to determine if they are safe and effective. The FDA’s role is to oversee the research conducted by pharmaceutical companies…” The results of the trials are obtained by the pharmaceutical company and given to the FDA.
Does this mean the prescriptions in your medicine cabinet don’t work? No…but it does mean they work only as well as the people who make them say they do.
Do you trust the FDA stamp of approval? I used to. Now I’m not so sure.
* Just a note on the other side of the argument. The Life Extension Foundation, authors of Life Extension Magazine, sells vitamins and supplements. Could their reports about the FDA be biased?
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