Replies to This Discussion

Permalink Reply by Scott Strumello on June 7, 2007 at 9:22am

Actually, I think the biggest issue isn't politics, it is the way the FDA is funded. Basically, in the words of The Boston Globe, "... in 1992, Congress put the fox in the chicken coop. It passed the Prescription Drug User Fee Act, which authorizes drug companies to pay "user fees" to the FDA for each brand-name drug considered for approval. Nearly all of the money generated by these fees has been earmarked to speed up the approval process. In effect, the user fee act put the FDA on the payroll of the industry it regulates. Last year, the fees came to about $300 million, which the companies recoup many times over by getting their drugs to market faster.

Unfortunately, Congress got very used to the FDA being largely self-funded, therefore they have given little money to the FDA to ensure public safety. This applies not only to drugs, but also to our food. Last year, there were several prominent outbreaks of eColi in spinach and other vegetables that are supposed to be managed by the Food and Drug Administration.

The Washington Post opines that its time to break the FDA from its user fee habit.

Insulin users are not immune to these problems, either. Did you know that the FDA requires no batch testing of insulin made via rDNA technology? The U.S. Patent and Trade Office filing for Humulin shows that potency of insulin made via synthetic processes can vary by up to 20%. It can be managed, but do you really want a for-profit business to police itself? There are only 3 companies selling insulin, so your choices are pretty limited. While I don't believe there is a conspiracy theory, I do believe that regulators should be working for public interest, not the needs of the drug industry, but thats not the way it now works.

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Permalink Reply by Lindsey F on June 13, 2007 at 9:06pm

Hi Manny,

I actually sell Actos and wanted to share with everyone that this warning on edema and CHF has been in the Actos and Avandia label since 1999, when both drugs were put on the market. It says in plain text under "Warnings" that TZDs can or may cause edema and exacerbate Congestive Heart Failure, and says to not give to patients with CHF Class III or IV. Takeda Pharmaceuticals (the actual manufacturer of Actos and who I work for) and Glaxo Smith Kline have been in talks with the FDA about making this a "boxed" warning to heighten the awareness of this. This is based on no new data, only emphasis on the warning that already exists. TZDs caused edema in only about 7% of patients in initial trials. Physicians are always warned about this and some physicians do not comply. This is why the FDA has made these already existing warnings a "boxed" warning.

Also, I want to make clear that this is not a result and is a separate issue from Dr. Nissen's meta-analysis in the New England Journal of Medicine regarding Avandia's MACROVASCULAR COMPLICATIONS. The FDA recently changed the label of Actos' Prescribing Information to include the first and only outcomes study on a TZD. Over 5,000 patients with Type 2 diabetes and a history of cardiovascular disease (heart attack, stroke, acute coronary syndrome, etc.) were studied for over 3.5 years. These were very sick patients. Actos was shown to have no increase in mortality or macrovascular events. The FDA felt that this evidence was so compelling that they changed the PI for Actos. Actually, if you look at the PI, there is a table in there to show the results from both arms of the study. Actos had less "events", including death, heart attack, stroke, etc.

So I hope this makes patients taking Actos feel better! As an Actos sales rep, I am going out everyday, pounding the pavement, making sure all physicians and patients feel comfortable taking Actos. We hear worries since these drugs are in the same class, but look at it this way: You have in front of you identical twins. They look alike, may even act alike, but their fingerprints are what keep them different. Actos and Avandia are PPAR agents and each one has a different molecular fingerprint.

Lindsey

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Permalink Reply by Manny Hernandez on June 14, 2007 at 3:38am

I was unaware of this, Lindsey. It's good to hear both sides of the story, indeed.

Thanks for shedding additional light on this.

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Permalink Reply by Lindsey F on June 15, 2007 at 4:57am

Hey!

I also wanted to let everyone know that they can call this number, 1-877-TAKEDA7, if they have questions regarding Actos, or go to www.actos.com. Have a great day!

Lindsey

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Permalink Reply by BgFelix on September 7, 2007 at 9:51am

Thanks for the numbers! Helps.

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Permalink Reply by dmills on June 18, 2007 at 11:50pm

Hi Manny,

I take Actos. In fact, it enabled me to get off of insulin. For that I'm thankful!

The possible connection with CHF, worries me. The scientific stuff is way over-my-head. I have a history of CHF. Just how concerned do you think I should be?

Thanks for bringing the subject up (I guess). ;)

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Permalink Reply by Jack Purvis on July 31, 2007 at 1:14pm

This NY Times article does speak to Actos (similar risk to Avandia), albeit briefly.

J

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Permalink Reply by Melissa Padilla on June 30, 2007 at 12:38pm

I took Actos for about 8 or so months. I can't say it did me any good, but I can say that it caused me to gain a considerable amount of weight! Nothing else had changed. My diet and all was the same as it had been. I took myself off it finally, as I dont' have insurance, and it costing me $130/month, and I didn't feel it was doing me any help. I was right!

My dad was on Avandamet, he too gained alot of weight, and had an acute pulmonary edema attack, just after a surgery to manipulate his shoulder. He nearly died!! Was on a ventilator for a couple days .... barely hanging on! I will go to my grave saying that the Avandamet is was brought that on!

Not that I need them, but I'll NEVER take Actos again, nor will I EVER take Anyting Avandia.

Just my experiences and feelings. I know things work/react differently with each of us. Some have had very good luck with these meds. I'm just not willing to take that risk.

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Permalink Reply by Manny Hernandez on July 27, 2007 at 6:45am

More news about Avandia and the FDA this morning:
http://tudiabetes.com/profiles/blog/show?id=583967%3ABlogPost%3A22182

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Permalink Reply by Jenny on July 27, 2007 at 7:18am

Manny,

There's even worse news that just showed up today--a study that had been published in Diabetes Care on May 29, but only in an abstract form that didn't make clear what its results meant. Turns out that 1 in 50 people taking Avandia AND Actos were hospitalized for heart failure and the data makes it look like the drugs are causing heart failure in relatively young people who did not have it to start with.

This shouldn't be a surprise. These drugs pack on huge amounts of water weight on people and this probably stresses the heart.

Links to the studies and media discussion on the new page I've split out about Actos and Avandia on my http://www.phlaunt.com/diabetes site HERE

If nothing else, this should really be a wake up call to all of us to keep up with the research about any drug we are taking. I was writing about the edema issue with these drugs in 2003 because the studies had already been published flagging the problem.

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Permalink Reply by Manny Hernandez on July 27, 2007 at 11:07am

WOA... that was intense. I was unaware of the May 29 study. :S

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Permalink Reply by Manny Hernandez on July 29, 2007 at 5:24am

Those of you who have a Digg.com account, make sure to digg this story:
http://digg.com/health/STUDY_Two_popular_Diabetes_drugs_may_double_...

It's already achieved popular status, which is VERY rare for diabetes-related stories.

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