The Merck/FDA problem.

[S Foote.]

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 other drugs that have been withdrawn from the market, finasteride usage has an obvious analogue that appears in Nature: the so-called "pseudohermaphrodites" in the Dominican Republic.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.

Actually, I was thinking more along the lines of CATASTROPHIC medical problems that some people worry about happening with long-term use, like cancer or heart disease. I maintain that the experience of the "pseudohermaphrodites" seems to rule that out! I can't understand why anyone would take such claims seriously (finasteride and major health problems), with the 30 years of study of the pseudo's that we have.

However, I'll concede the point you made about the sexual issue. But doesn't it seem a bit odd that there's no clear information about that, one way or the other, in the medical studies? If they had major sexual problems, wouldn't that have been reported long ago? In any event, I'll try to find out more about that particular issue...

Bryan

It seems that the accuracy of conclusions drawn from the study of pseudo's, has been questioned because of the limited gene pool.

http://www.gender.org.uk/chstnuts/mcginley.htm

S Foote.

 

[Guest]

LOL!! Umm...is it at least ok if I quote PhD's in biochemistry and medicine who say that the drug is safe??

Sure. Is it at least OK if I quote the PhD's in biochemistry and medicine who say that the drug isn't?

Axon wrote:
But I tire of these posts from people without PhDs in Biochemistry telling me that the drug isn't safe. Get your degree and prove that it isn't safe...

Touché!

Bryan

Yeah, he really got me.... See my response, B. I look forward to your next puzzle. Not.

 

[Axon]

I'd certainly be willing to listen to any PhD's who have a double-blind, long-term study showing that Finasteride causes siginificant side effects in men.

 

[Guest]

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??

The people.

That doesn't make much sense to me. I can possibly see someone in the corporation claiming a conflict of interest, but not the people.

Bryan

It would be very easy for a large pharmachutical company to employ, on a generous salary, a former FDA employee who was seen to favour the pharmachutical company on issues where the companies interest were weighed against the public interest. I think this would send a very clear message to those few less than scrupelous individuals looking for a nice retirement on the board of a large profitable company. At worst it could lead to a symbiotic culture between the large pharachuticals and the FDA.

This is not in the best interests of the public.

 

[Bryan]

It seems that the accuracy of conclusions drawn from the study of pseudo's, has been questioned because of the limited gene pool.

http://www.gender.org.uk/chstnuts/mcginley.htm

Stephen, the article at that link is an interesting but peculiar rant by the author about certain psycho-sexual issues having to do with the pseudo's. It doesn't seem particularly relevant to what _I_ was talking about, which is whether or not SERIOUS and CATASTROPHIC illnesses like cancer and heart disease are caused by either 5a-reductase deficiency or inhibition.

Bryan

 

[S Foote.]

It seems that the accuracy of conclusions drawn from the study of pseudo's, has been questioned because of the limited gene pool.

http://www.gender.org.uk/chstnuts/mcginley.htm

Stephen, the article at that link is an interesting but peculiar rant by the author about certain psycho-sexual issues having to do with the pseudo's. It doesn't seem particularly relevant to what _I_ was talking about, which is whether or not SERIOUS and CATASTROPHIC illnesses like cancer and heart disease are caused by either 5a-reductase deficiency or inhibition.

Bryan

I see it as an example of how studies can be presented as more relevant than they actually are to a particular issue Bryan.

The authors `rant' as you put it, is a ligitimate critique of assumptions being made without proper foundation.

Something that i suggest has been done in hair loss research for years!

S Foote.

 

[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?

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

The people.

That doesn't make much sense to me. I can possibly see someone in the corporation claiming a conflict of interest, but not the people.

Bryan

It would be very easy for a large pharmachutical company to employ, on a generous salary, a former FDA employee who was seen to favour the pharmachutical company on issues where the companies interest were weighed against the public interest. I think this would send a very clear message to those few less than scrupelous individuals looking for a nice retirement on the board of a large profitable company. At worst it could lead to a symbiotic culture between the large pharachuticals and the FDA.

This is not in the best interests of the public.

This does in fact happen very often thats one of the reasons the FDA has come under fire by watchdog groups and not just the FDA but the FCC,
EPA many in government agecnys and politicians..what amazes me Bryan is you actually ask whos conflict of interest?..are you that naive? YOu side with the multi-national rather than the people on this issue?

 

[jason566]

Ok maybe your saying the corporation would be like hey why we hiring a guy or woman who use to regulate on us and enforce standards and these regulations etc..but the thing is it shows how much reforming these angenys need and how buddy/buddy at times certain indviduals become with these very same coporations who those same people are paid to keep an eye on..these agencys were created to protect the public interest not protect say Merck or Fpizers or whoever profit margin..

 

[Bryan]

What I'm saying is that I think it's naive to think that a drug company is going to be able to pull strings or have some kind of influence on the FDA, just because they happen to hire somebody who had previously worked for the FDA. I think such conspiracy theories belong on the Art Bell show!

Bryan

 

[jason566]

Its not a comspiracy theory as u have put it..
its a matter of fact this is not about what side of the politcal fence u rest on but this is happening people are taking jobs in an industry they want to regulated it happens alot more than you think..ask anyone heavily involved in washington im sure they would tell you that it happens..pick up an issue of well walla street journal or new york times..READ

 

[not me!]

LOL!! Umm...is it at least ok if I quote PhD's in biochemistry and medicine who say that the drug is safe??

Sure. Is it at least OK if I quote the PhD's in biochemistry and medicine who say that the drug isn't?

You guys quote the PhD's. I'll wait for the reports from the MD's

 

[Guest]

What I'm saying is that I think it's naive to think that a drug company is going to be able to pull strings or have some kind of influence on the FDA, just because they happen to hire somebody who had previously worked for the FDA. I think such conspiracy theories belong on the Art Bell show!

Bryan: how old are you? And have you read any printed material--news media in particular--during the past decade to decade and a half you've been alive? If not, begin doing so; also, a good tip: don't believe everything Fox News says. It's not *real* news!

 

[hair mchair]

What I'm saying is that I think it's naive to think that a drug company is going to be able to pull strings or have some kind of influence on the FDA, just because they happen to hire somebody who had previously worked for the FDA. I think such conspiracy theories belong on the Art Bell show!

Bryan

I wouldn't label this a "conspiracy theory." It's basic human nature. In the business world, it's all about connections. If you work for the FDA, or any government agency really, and you can use your position to establish strong connections with the industry you regulate, then you will likely do so if your self-interest outweighs your interest in the public good. You help grease the wheels a little for the drug companies while you're in the FDA, and you'll have a nice position waiting for you with Merck or GSK in a few years when you retire.

 

[Guest]

What I'm saying is that I think it's naive to think that a drug company is going to be able to pull strings or have some kind of influence on the FDA, just because they happen to hire somebody who had previously worked for the FDA. I think such conspiracy theories belong on the Art Bell show!

Bryan

:roll:

 

[Bryan]

Its not a comspiracy theory as u have put it..
its a matter of fact this is not about what side of the politcal fence u rest on but this is happening people are taking jobs in an industry they want to regulated it happens alot more than you think..

Sorry, I don't understand the last half of that sentence. Neither am I sure what any of this really has to do with which side of the "political fence" you happen to be on. Are you assuming that only conservative Republicans are susceptible to corruption? :wink:

ask anyone heavily involved in washington im sure they would tell you that it happens..pick up an issue of well walla street journal or new york times..READ

It would tell me that WHAT happens?

Bryan

 

[Bryan]

Bryan: how old are you?

I'm 54 years old.

And have you read any printed material--news media in particular--during the past decade to decade and a half you've been alive?

Yes I have.

If not, begin doing so; also, a good tip: don't believe everything Fox News says. It's not *real* news!

I wouldn't be caught dead listening to Fox News. For electronic media, I've listened to NBC news since I was a kid.

Bryan

 

[Bryan]

What I'm saying is that I think it's naive to think that a drug company is going to be able to pull strings or have some kind of influence on the FDA, just because they happen to hire somebody who had previously worked for the FDA. I think such conspiracy theories belong on the Art Bell show!

I wouldn't label this a "conspiracy theory." It's basic human nature. In the business world, it's all about connections. If you work for the FDA, or any government agency really, and you can use your position to establish strong connections with the industry you regulate, then you will likely do so if your self-interest outweighs your interest in the public good. You help grease the wheels a little for the drug companies while you're in the FDA, and you'll have a nice position waiting for you with Merck or GSK in a few years when you retire.

Please note that that's a different scenario from what I described originally. Furthermore, YOUR scenario sure as hell isn't just "human nature", it's out-and-out CORRUPTION, if it's done intentionally. Let's hope that it's rare, if it occurs at all.

I stand by what I said about MY scenario.

Bryan

 

[The Gardener]

I agree with Bryan.

First off, generally speaking people do not leave jobs in the regulatory agencies to take jobs at the big pharma companies. Here in the States, the trend is the other way round. Usually, people burn out from high level jobs in big corporations and land snooze-alarm jobs in our marvelous bureaucracy... jobs where they are not paid to DO, but paid to THINK and collect nice Federal bennies for their family and progeny. For high profile examples of this, think Cheney, Snow, Rumsfeld, Venemin, etc.

Second, before launching attacks at the FDA claiming they place human health secondary to profit, I suggest looking at historical evidence first. Sure, Xioxx or whatever that drug is called slipped through the net and had a long term detrimental effect on heart health. But, to take the example of one drug and broadbrush the entire regulatory process is a cheap shot. Think of just how many drugs are developed and created each year, and are succesfully used to improve people's lives with safety. I trust the FDA. I mean, come on here, folks... one drug slips by, and it is not like it is some death drug that has killed thousands or something. It is a drug that has a slight long-term increase in a certain health risk... to take that and conclude that the FDA and the pharma companies are in league to screw citizens' health is stupid.

Also take into account the response to the problem. When the problem was identified, the FDA put the heat on the companies, as did Wall Street, and the stock price took an immediate 30% hit. So, how exactly did this help the 'profit' of said pharma company?

I think this thread is just the paranoid scare of the week... along with the many others that have occured here over the year I have been posting here. And, for the record, I am no conservative nor friend of the Bush administration but I think this thread is needless scaremongering. A little PERSPECTIVE please.

 

[Guest]

YOUR scenario sure as hell isn't just "human nature", it's out-and-out CORRUPTION, if it's done intentionally. Let's hope that it's rare, if it occurs at all.

Bryan

Do not hope against out-and-out CORRUPTION, legislate against it.

 

[Bryan]

YOUR scenario sure as hell isn't just "human nature", it's out-and-out CORRUPTION, if it's done intentionally. Let's hope that it's rare, if it occurs at all.

Bryan

Do not hope against out-and-out CORRUPTION, legislate against it.

As if corruption were LEGAL at the present time??

Bryan