The Merck/FDA problem.

[Jaygee]

Hi. I'm not trying to be an alarmist here, but I want to raise this question.

I was surprised when the Vioxx fiasco never came up around here. (Only just today did someone make an indirect reference to it). It got me a little antsy, but I didn't panic or anything. Now with Celebrex's surprise withdrawal (you know, I *thought* they were being a little too cocky lately), the FDA has suddenly come under a lot of media scrutiny, as I'm sure some of you have noticed. There are all these reports on CNN and what have you about certain congressmen calling for massive overhauling of the way the FDA operates, and the need for much better scrutiny and monitering of drugs on the market. Included in the report was a confirmation of my worst fear---there has indeed been an atmosphere of pressure at the FDA to get new drugs tested and on the market quickly. I think they said that in 1992 or something a law was repealed that forbade the FDA's studies from being financed directly by the pharmacuetical companies themselves, thus giving the drug industry much greater power. In the case of Vioxx, it's now known that Merck kept troubling data on the stuff hidden for over three years.

What I'm trying to say is, both Merck and the FDA have come away from all this looking less than stellar. I realize that finasteride has nothing to do with the drugs contained in Vioxx, but both were subject to FDA testing and Merck marketing pressure. Many already strongly suspect that the 2% figure for Propeica side effects is a significant underestimate. What else might we need to know that many of us don't?

I'm very sorry for my gloomy tone, but this does worry me when I stop to think about it. I realize, again, that finasteride is much less potent drug than the persona non grata Vioxx, but it has the same parents---Merck and the FDA. And as much I want to trust those parents, they've been revealed to have not always been either as honest or as thorough as they should be.

If anyone else has thoughts on this, let's hear them. The last, LAST thing I want to do is scare newbies and lurkers, but it's better to have everything on the table when visitors come in.




As a side note, the Vioxx issue has got me a little spooked about the reliabilty of Cipla, where I get my generic finasteride. Last time I checked, they were still offering Vioxx. I see this as grotesqely irresponsible of them. They must know what's been revealed.[/i]

 

[Axon]

Too bad propecia doesn't sell for sh*t. So the pressure motive can probably be ruled out. As for it being Merck and FDA related, well, what do you expect? That's the number 2 drug company in the world and the #1 drug authority in the states. How many drugs come out that are safe? Countless.

Personally, I refuse to live my life under the shadow of media scaremongering. I'm a former journalist and I know how they get down. They salivate over stories like this because it's months worth of news for them, and frankly, bad news sells.

The number of people that suffer heart trouble specifically because of Vioxx remains to be seen. That being said, if there's a way to reform the FDA, I'm all for it.

But hey, if you don't wanna take Finasteride for whatever reason, just don't.

 

[Bismarck]

Good post Jaygee. I agree with you, Merck certianly hasn't revealed all the data they had. But even if they did so - there is always the risk of long-term side effects. Maybe even Merck is unable to anticipate them.

bis

 

[Matgallis]

Yea propecia doesn't sell for sh*t compared to their other drugs, but they still make millions off propecia annually.

 

[Axon]

Which, to them, is barely worth being concerned over. Why keep info hidden on a drug that isn't a top seller? Vioxx was bread and butter, their #1, they had a reason to protect it.

 

[Jaygee]

I have no plans to stop gulping finasteride unless it turns out to just plain not work for me. (Month 6.5 and no change except for thinning of right temple. Hopefully temporary). I'm not too worried about it affecting me personally, since the side effects are 97% gone (I can live with the 3%, which means less "spontanaiety"). There is always the remote possiblity that long-term use is carcinogenic, but of course if that turns out to be true it's not Merck's fault. Who could have known?

All I'm saying is that I wish I trusted the FDA's testing methods more. It makes me less certain than I would like to be about their finasteride success percentages-----not to downplay all the success stories on this site.

Of course, it seems like "trust" is an increasingly relative concept these days. So you gotta take 'em as they come. 8)

 

[Jaygee]

To our benefit, HairLossTalk.com has documented the Propecia trials pretty well for us.
So there is that.

Axon---Yer prob'ly right about their prioritizing secrecy about their major breadwinner over a surprisingly modest seller.

My grandmother was one of those Vioxx users left out in the cold by the ordeal, and who ended up on---of course---Aspirin again. So far so good.

 

[Old Baldy]

Yes, it seems finasteride. is safe. Producing it is probably based on a standard successful manufacturing process.

You guys are right though, just because a Government agency approves a drug doesn't mean it is "good as gold".

I remember reading an article a while ago where the head of the FDA in the early 1950's said diet has no bearing on disease.

That could be the one of the most idiotic statements I ever read. Yet it was quoted from the head of the FDA.

We've got a long way to go guys.

 

[jason566]

you also have the problem of people who work in these government agencys and polticiains whos job it is to make sure these drugs are safe for public use..taking jobs later after there tenure with the government taking jobs at these same exact multi-national giants who they were at one time paid to enforce laws on..some could see this as conflict of interest?..its very worrisome to know that say the head of the FDa could one day sit on the board of say Merck or Pfizer

 

[Bryan]

you also have the problem of people who work in these government agencys and polticiains whos job it is to make sure these drugs are safe for public use..taking jobs later after there tenure with the government taking jobs at these same exact multi-national giants who they were at one time paid to enforce laws on..some could see this as conflict of interest?

A conflict of interest from WHOSE point of view?? The people, the government, or the corporation??

..its very worrisome to know that say the head of the FDa could one day sit on the board of say Merck or Pfizer

Worrisome for whom? The corporation, or society in general? :wink:

Bryan

 

[Bryan]

What I'm trying to say is, both Merck and the FDA have come away from all this looking less than stellar. I realize that finasteride has nothing to do with the drugs contained in Vioxx, but both were subject to FDA testing and Merck marketing pressure. Many already strongly suspect that the 2% figure for Propeica side effects is a significant underestimate. What else might we need to know that many of us don't?

Oh, for God's sake. As I've done numerous times before, I'll point out once again that unlike Vioxx and most (all?) other drugs that have been withdrawn from the market, finasteride usage has an obvious analogue that appears in Nature: the so-called "pseudohermaphrodites" in the Dominican Republic. Finasteride causes the same alteration in hormones that those guys experience their entire lives, and they appear to be healthy individuals (with the obvious exception of their early genital development). Their apparent life-long health should be a significant comfort for Propecia and Proscar users. Don't lose too much sleep over using finasteride.

Bryan

 

[S Foote.]

Bryan Said:

"Oh, for God's sake. As I've done numerous times before, I'll point out once again that unlike Vioxx and most (all?) other drugs that have been withdrawn from the market, finasteride usage has an obvious analogue that appears in Nature: the so-called "pseudohermaphrodites" in the Dominican Republic. Finasteride causes the same alteration in hormones that those guys experience their entire lives, and they appear to be healthy individuals (with the obvious exception of their early genital development). Their apparent life-long health should be a significant comfort for Propecia and Proscar users. Don't lose too much sleep over using finasteride. "

I have to question your very un-scientific assumption here Bryan?

The pseudohermaphrodites studied are very few in number, 47 as i recall. More importantly, they all share a common genetic background which is why they inherited the condition in the first place!

Their particular genetic `package' may not dispose them to a whole range of medical conditions, that other people may inherit through `their' particular genetic background. Reducing DHT in some people could therefore interact with a pre-disposition to cause adverse events?

For example, autoimmune diseases run in families, so there is some kind of genetic pre-disposition. My theory predicts that reducing levels of DHT will create significant changes in tissue immunology. If so, this would increase risk of autoimmune disease in individuals with an existing pre-disposition.

I put this question to Merck and the FDA, and the CSM here in England. I asked if Finasteride did cause this predicted change in tissue immunology?

Merck, the FDA and the CSM, all refused to comment on this question. I tried every avenue i could to get a response over a considerable period. My member of Parliment even tried to get a reply directly from the Dept of Health here. They just said this was confidential information!

My view is, if Finasteride does `NOT' have the predicted effect, why not just say so!

S Foote.

 

[Roberto]

My view is, if Finasteride does `NOT' have the predicted effect, why not just say so!

Probably because anything they say other than "no-comment" increases their potential risk of legal liability in case future events do uncover something - I wouldn't necessarily take it as them hiding anything.

But count me among those that are doubting the 2% number for sexual side effects of finasteride. I wouldn't be surprised if its the majority of users that are affected if you count milder downgrades on libido and erectile function that are livable-with for most guys.

 

[hair mchair]

Oh, for God's sake. As I've done numerous times before, I'll point out once again that unlike Vioxx and most (all?) other drugs that have been withdrawn from the market, finasteride usage has an obvious analogue that appears in Nature: the so-called "pseudohermaphrodites" in the Dominican Republic. Finasteride causes the same alteration in hormones that those guys experience their entire lives, and they appear to be healthy individuals (with the obvious exception of their early genital development). Their apparent life-long health should be a significant comfort for Propecia and Proscar users. Don't lose too much sleep over using finasteride.

Bryan

"Their apparent life-long health"??? Bryan, I've asked you in the past if you knew whether or not these Dominican pseudohermaphrodites have any sexual disorders, and you replied that you did not know. I consider sexual health to be a facet (and an important one at that) of one's overall health. It may not involve life-threatening factors, but it's still a health issue and a quality of life issue.

So if you are still unable to answer the question I've posed to you in the past, I don't think you can assert that these men are the perfect pictures of health since you don't have the full story. I still maintain, based on my own experience and the experience of many other men I've talked to, that finasteride is capable of causing long-term sexual disorders in a small percentage of men, many years after discontinuation of the drug.

Btw, S Foote., very interesting post. Another point to consider is that artificially producing, via medication, a naturally-occuring phenomenon might have unforeseen consequences.

 

[hair mchair]

Which, to them, is barely worth being concerned over. Why keep info hidden on a drug that isn't a top seller? Vioxx was bread and butter, their #1, they had a reason to protect it.

Not sure I'm following your line of reasoning. I would think a drug company would want to keep info hidden on ANY drug, top seller or not. As long as they are making money off of it, why would they want to risk having it pulled from the market?

 

[Axon]

Which, to them, is barely worth being concerned over. Why keep info hidden on a drug that isn't a top seller? Vioxx was bread and butter, their #1, they had a reason to protect it.

Not sure I'm following your line of reasoning. I would think a drug company would want to keep info hidden on ANY drug, top seller or not. As long as they are making money off of it, why would they want to risk having it pulled from the market?

Their incentive is not as great to keep it on the market. They know they can still be subject to suit if Finasteride was suddenly discovered to cause cancer. However, since it doesn't sell that well, they have minimal incentive to hide that data, as they did with Vioxx. They wanted to keep Vioxx on the market. The profit margin outweighed the risk of discovery.

 

[Axon]

BTW hair, ever work out the disorder?

 

[hair mchair]

Their incentive is not as great to keep it on the market. They know they can still be subject to suit if Finasteride was suddenly discovered to cause cancer. However, since it doesn't sell that well, they have minimal incentive to hide that data, as they did with Vioxx. They wanted to keep Vioxx on the market. The profit margin outweighed the risk of discovery.

Makes perfect sense to me now. Thanks for clarifying that. Of course, this depends on the nature of the problem caused by the drug. With something like cancer or heart disease, Merck would have a hard time playing the plausible deniability card. With a problem like mine, however, they can easily get away with it.

I haven't made any consistent progress with my disorder, no. I'm still trying though. I'll be seeing my doctor again soon. Thanks for asking.

 

[Guest]

However, since it doesn't sell that well, they have minimal incentive to hide that data, as they did with Vioxx. They wanted to keep Vioxx on the market.

Seeing as the underlying logic of this argument is that Merck will hide data at the risk of losing profit--be it substantial or no--I don't find any reassurance here. Not to mention, the FDA has for 12 years suffered decreased funding that has all but eliminated post-market trials for drugs. If Propecia does increase the chance of cancer, we probably won't find out until someone who's taken it for 15-20 years gets cancer; we become the guinea pigs for these drugs as soon as they leave the complacent FDA. Sure, journalists are eager for a story; but to have more than a modicum of trust in the FDA or a major pharmeceutical company smacks of naivete and ignorance. If you're not taking Propecia for prostate cancer, or to prevent it, you are arbitrarily jeopardizing your health--no two ways about it. I tire or reading posts from people without medical degrees trying to assuage these fears. Get your PhD in biochemistry and medicine, and then tell me the drug is safe.

By the by, I, too, use Propecia, though I'll likely discontinue using it because of its total ineffectiveness.

 

[Brasileirao]

n/t