FDA review

Does anyone know what happened to the FDA review of Propecia? It seems that Merck put their site up again, but its different this time. I wonder if they did that because of the examiner articles.

Still going on I assume the government takes time.

I wonder how they are conducting their review thou, I doubt they have contacted any of us. At least I have not heard anything, it makes sense to contact the people suffering from the sides, I don’t see how they could determine its safety without doing that. Maybe they are doing another trial but I doubt that. Probably just going off of current existing data, which is limited. I wouldn’t be surprised if they came back and said that according to their research its safe, because if they don’t research the people who have been hurt by it and just go by the limited studies on the negative effects thats all their going to find.

You mean they use the existing studies by Merck? What is it going to take to get this drug banned?

I don’t know what they use. I was thinking they might use Irwigs study and the boston university study as evidence of side effects.

The whole process is a joke.

Never in my worst nightmares could I imagine that a drug for such trivial purposes could cause such horrific problems and be completely disregarded by the drug monitoring bodies for years on end. Maybe I should have paid more attention to the Vioxx thing.

I sent my e-mail to the relevant people about my experience and got a little sentence saying they were sorry I had suffered so much pasted on to a generic letter basically saying ‘you were unlucky, shit happens’.

“You know who” is doing everything in their power to derail, stall, and sanitize this issue before the law suits get to court. I’m sure they don’t want to walk into court trying to defend a drug that has been pulled off the market or black labeled after the fact. The FDA might have some egg on it’s face too if all the facts were exposed here. Giving an anti-androgen cancer medication the green light to be used for hair loss of all things doesn’t excactly fit with their mission statement. I think we’re getting a horse and pony show here, at least so far.

Yup, and how many employees of the FDA are former employees of Merck?

Actually, Dr. Dada contacted me personally. And she seemed very concerned. I recommended everyone call her if they haven’t already.

Senior Health Promotion Officer
Division of Drug Information
301-796-3105
Kavita.Dada@fda.hhs.gov

This is my current project as of now, but won’t make any announcements till things come to fruition. Note my sig. This laughable statement was to the FDA review panel.

Ok, I will contact him/her. I highly suggest everyone else does the same as SA said.

I called her, basically she just said to just submit a medwatch report which I have already done. I asked her about speaking with the person in charge of the safety review of finasteride and she said she was on vacation.