FDA Strikes Again

[Guest]

Can I get a job that I suck at and make a ton of money too?!?!?

FDA's Mission Statement

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

This just in:

Avandia Alert

Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.

FDA Issues Safety Alert on Avandia

Aren't they supposed to do these trials before they release the drugs?!?!?!?

 

[Guest]

As usual, the edit feature is screwed up so I couldn't correct this, I put the wrong link so here ya go:

Can I get a job that I suck at and make a ton of money too?!?!?

FDA's Mission Statement

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

This just in:

Avandia Alert last year wasn't enough:

Now this:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=78#1

Aren't they supposed to do these trials before they release the drugs?!?!?!?

 

[Guest]

Well, I guess it is a good time to be a trial lawyer. I am sure we will see the "Have you taken Avandia" commercials any day now.

 

[arnguy]

Rob, did you notice the date on that press release? It's May 21, 2007. Actually this was publicized some moths ago on network news. The VA medical pharmacy system began offering Actos (a similar drug, but supposedly less harmful) over 6 months ago as a substitute for Avandia. My understanding is that some private physicians are still prescribing Avandia. Gosh, shades of Vioxx!

 

[Guest]

Hey Arn,
yes I noticed, wrong link, I tried to correct it but the bugs on the forum wouldn't allow it. Check this one out. Sorry about that.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=78#1

They must be out to get diabetics or something!!

 

[Guest]

Wow, the FDA is tricky, it redirects, I see this on the link I copied and pasted from the Patient Safety news section:

Show #78, August 2008

[SIZE=+1]Warning Added to Regranex Label[/SIZE]

A boxed warning alerting healthcare professionals to an increased risk of cancer death has been added to the labeling for Regranex (becaplermin), a topical medication used to treat certain diabetic foot and leg ulcers.

Based on a review of an earlier epidemiologic study, FDA has concluded that patients who use three or more tubes of Regranex experience a five-fold increase in the risk of cancer death compared to patients who do not use the drug. The duration of the study was not long enough to establish whether there is also an increased risk of new cancers.

In March 2008, FDA announced that it had received the epidemiologic study, described what the overall study findings were, and promised to analyze the study and communicate its findings to the healthcare community. The new boxed warning in the labeling is the result of that analysis.

Foot ulcers are a serious problem among diabetics, and yet there are few treatment options. FDA says that Regranex can be effective when it is used along with good ulcer care practices, such as controlling infection, removing dead tissue and relieving pressure. However, the boxed warning says that Regranex should only be used when the benefits are expected to outweigh the risks, and that it should be used with caution in patients with known malignancies.

 

[seadevil]

Being someone who is diabetic and takes Avandia, I guess I can comment on this. When the report first came out I was somewhat concerned and spoke to my Dr. about it. I continue to take the medicine because it seems to do the best with keeping my sugar levels down. Also, when I spoke to my Dr. he explained the pro's and con's, where the study was conducted and where the people who passed away were from. Also, based on what he had read and different symposiums he had attended, those who did pass away, not only had diabetes to worry about.

I can honestly say that if there is a class action lawsuit I will not be submitting my name to be a part of it. I was given the option of switching medications and I chose to continue with my original prescription. I guess if I have a heart attack, Avandia may have been a part of it, but also my love of certain foods is probably the real reason.

 

[Guest]

Being someone who is diabetic and takes Avandia, I guess I can comment on this. When the report first came out I was somewhat concerned and spoke to my Dr. about it. I continue to take the medicine because it seems to do the best with keeping my sugar levels down. Also, when I spoke to my Dr. he explained the pro's and con's, where the study was conducted and where the people who passed away were from. Also, based on what he had read and different symposiums he had attended, those who did pass away, not only had diabetes to worry about.

I can honestly say that if there is a class action lawsuit I will not be submitting my name to be a part of it. I was given the option of switching medications and I chose to continue with my original prescription. I guess if I have a heart attack, Avandia may have been a part of it, but also my love of certain foods is probably the real reason.

Well I appreciate your honesty and that's unfortunately part of the problem. Take a drug and the band aid leads you to believe the condition is okay or acceptable. Many people don't stop what's potentially harmful, smoking, whoring, crack etc.

Then they complain about insurance and their health later on when it's too late. (I'm not accusing you)

I was amazed when my Uncle died horribly of cancer directly related to two packs of Lucky's a day, and there they are, people at the wake saying "what a shame" while outside smoking!



PS: Hopefully your doctor isn't biased and you actually received a real evaluation of the product. Check this as if we didn't know:

Sick of the High Cost of Prescription Drugs?

Drug companies spend billions of dollars each year on gifts to influence doctors to prescribe their newest brand-name drugs when less expensive but equally effective drugs may be available. These marketing practices can drive up the cost of health care for the state, your local government, and everyone who pays taxes or insurance premiums.

What your doctor prescribes should be determined solely on your best interest and his best judgment based on science and research - not gifts from drug companies.

During the recent state legislative session, AARP supported a bill (S.2971) that would have required drug companies to publicly report gifts they give to doctors valued at $75 or more.

 

[seadevil]

Rob,
I agree, yes there is a problem with people going the band aid route or just taking their Dr.'s advice 100%. In my case when the FDA came out, I did the research. I also took the research with me when I met with my Dr., who I get to see at a minimum 4 times a year. Each time everything is checked with my diabetes. One thing that I specifically requested was that on every visit I wanted a Liver Function test. When I found out I was diabetic, I was within 5 mos of retiring from the Navy. The Dr. and my Corpsman told me that I should have this test at least semi-annually. However, I researched the hell out of this and found out that being diabetic and taking different medicines could lead to liver failure.

Unfortunately, it seems that most people either are too lazy to do the research or think that their Dr. is God. Personally I figured it's my health, I should at least have some idea what the Dr. is saying.

My goals is to completely get off the medication and control my diabetes with exercise and diet. However, for me that is not that easy, but working on it.

 

[Guest]

Rob,
I agree, yes there is a problem with people going the band aid route or just taking their Dr.'s advice 100%. In my case when the FDA came out, I did the research. I also took the research with me when I met with my Dr., who I get to see at a minimum 4 times a year. Each time everything is checked with my diabetes. One thing that I specifically requested was that on every visit I wanted a Liver Function test. When I found out I was diabetic, I was within 5 mos of retiring from the Navy. The Dr. and my Corpsman told me that I should have this test at least semi-annually. However, I researched the hell out of this and found out that being diabetic and taking different medicines could lead to liver failure.

Unfortunately, it seems that most people either are too lazy to do the research or think that their Dr. is God. Personally I figured it's my health, I should at least have some idea what the Dr. is saying.

My goals is to completely get off the medication and control my diabetes with exercise and diet. However, for me that is not that easy, but working on it.

You hit it right on the head, people think their doctor is God. I had a client who told me she goes to the doctor once a month to get her script renewed, a script that hasn't changed in two years!!! Think her doc was bangin' her out for nothing?

And again, I wasn't accusing you, of course you of all people would know the deal, being in insurance.

And keep at it, the things worth the most are rarely easy.