WTF is wrong with this world(revisited)?

[fritzi93]

Didn't know there were so many conspiracy mongers here. It's hardly news that the interests of big business and those of consumers are not the same. Caveat Emptor.

I can understand the criticism of the FDA. Drugs seem to get the OK here only after the rest of the world has them for years. But that's not invariably a bad thing. (Again, remember thalidomide. A morning-sickness drug that caused tens of thousands of severe birth defects in Europe. It was years before follow-up studies revealed that. Tests were much less rigorous then.) There are two sides to the issue.

[NamPla]

Again, remember thalidomide. A morning-sickness drug that caused tens of thousands of severe birth defects in Europe. It was years before follow-up studies revealed that. Tests were much less rigorous then.

It wasn't just Europe, fella.

[fritzi93]

Again, remember thalidomide. A morning-sickness drug that caused tens of thousands of severe birth defects in Europe. It was years before follow-up studies revealed that. Tests were much less rigorous then.

It wasn't just Europe, fella.

I'm going to assume from your tone you forgot the smiley. You also forgot to contribute any useful, specific information.

As I recall, the first studies showing the effects were European, British and German. It was most certainly never approved in the U.S. for morning sickness. For that, Americans can thank Dr. Francis Kelsey, head of the FDA in the early sixties.

Okay, did a Google. It was prescribed in Canada as well. Haven't found any mention it was used elsewhere. According to the March of Dimes, over ten thousand documented cases of severe birth defects are attributable to thalidomide. Thalidomide has been approved since 1998 for treatment of leprosy, and is currently being evaluated for used against AIDS, lupus, some cancers, etc.

[NamPla]

I knew an elderly woman who "miscarried" due to this guinea-pig shit. I knew a guy with "flap" arms, they were like flippers that couldn't reach his pockets. Thalidomide was/is alive and well in Australia (and Asia too)!

It was a worldwide thing, not just Europe.

(There were big court cases back in the '60s/'70s that dragged into the '80s!)...(Very hushed up)...

[vitualis]

Um, if wasn't approved by the FDA because of red tape: http://w3.aces.uiuc.edu:8001/Liberty/Tales/Thalidomide.html

It was really nothing more than a lucky chance.

Thalidomide was used worldwide, not just in Europe.

Regards.

[budz]

Yes in America it sucks because of the BIG DRUG COMPANIES and the government regulate the control of prescription drugs. In my opinion it is the FreEking Insurance companies that are making all the money. The medical insurance company HMSA which I am under had profit of 10.4 million dollars this year! They raise their rates, limit certain coverage and have these fReeking preferred medicines list which are the junk meds.

Amoxicillin is a broad spectrum antibiotic but their are newer better ones that are on the market like Zythromax. But no they don't cover Zythromax so if we want it we end up paying $35.00 for it . If it was on their preferred list of medications then we would only pay $15.00. Also if it is not a participating pharmacy with HMSA we end up paying more of a copayment for certain meds. My doc is great because I get the samples if the meds is not covered under my medical plan. I am thankful that I have medical coverage with a prescription plan because I know there are those in USA that have none at all. It's the medical insurance companies making the BIG BUCKS!!!!!

In the Clinton administration they tried to get Hawaii to be one of the states that would have med.coverage for everyone. One of my doctors was on that panel that went to D.C. The panel of doctors asked that Hawaii be excluded because we already have a law that states EMPLOYERS have to provide medical coverage for any employee that works 20 hours or more a week. Of course Clinton's plan didn't go through. Some companies in Hawaii get away from not providing medical coverage by only giving part time employees 19 hours a week.

Ok, I'm done rambling.

[vitualis]

Again, the problem with direct consumer marketing of medications. I am thankful that I don't have patients asking for "the better" antibiotic.

Don't you people understand? You are all falling into the drug companies ploy. They are grooming the market on multiple levels. Newer antibiotics aren't necessarily any better than older ones for common infections. In fact, they should be RESTRICTED so that they don't get used inappropriately which worsens the problem with antibiotic resistance.

For your common upper respiratory infection, there isn't much difference in what antibiotic you use simply as the majority of them are actually caused by a virus. In fact, you shouldn't be using an antibiotic at all unless it becomes obvious that it is a bacterial infection.

Regards.

[fritzi93]

Um, if wasn't approved by the FDA because of red tape: http://w3.aces.uiuc.edu:8001/Liberty/Tales/Thalidomide.html

It was really nothing more than a lucky chance.

Thalidomide was used worldwide, not just in Europe.

Regards.

My point is, the FDA is in the habit, sometimes rightly, sometimes wrongly, of delaying approval. Our news organizations are fond of doing stories on the latest 'wonder drug" used elsewhere. Been hearing such stories for fifty years, they're a hardy perennial.

As to the "lucky mistake", I can find other websites that do not put that interpretation on events.

www.cerhr.niehs.nih.gov/genpub/topics/thalidomide2-ccae.html

www.marchofdimes.com/professionals/681_1172.asp

So I think I'll refrain from calling it a lucky mistake.

I'll admit I somehow missed the fact that Japan and Australia approved the drug. Although the first website cited above mentions only Europe and Canada.

[vitualis]

I strongly suggest you read the British Medical Journal's editorial this month on the FDA regarding rofecoxib (Vioxx). Habit of delaying approval? They seem to be more in bed with the drug companies now than ever before... I wrote something about this recently in my blog: http://vitualis.blogspot.com/2004/11/something-rotten-in-fda.html

Regards.

[vitualis]

As to the "lucky mistake", I can find other websites that do not put that interpretation on events.

This is called revisionist history. It happens all the time.

In America, the FDA official in charge of the American "new drug application" for thalidomide (Nov., 1960) was a woman physician (Francis Kelsey, M.D.) whose physician/pharmacist husband did not like the way routine pharmacologic tests had been done on thalidomide. Dr. Kelsey was also concerned about some medical reports in late 1960 that thalidomide might cause neuropathy in some of its users. Neither of these concerns was fatal for the thalidomide application, but together they were enough to hold up the FDA's approval of thalidomide for a year. Since neither problem had anything to do with birth defects, it was only by the sheerest chance that the red-tape in these matters caused introduction of thalidomide to be delayed in the U.S. until it began to be suggested in late 1961 that thalidomide was a dangerous drug for pregnant women. In the end, the association between thalidomide and birth defects was discovered in Europe, not America -- and certainly was not discovered by the FDA. Despite this, on August 7, 1962 a grateful President John F. Kennedy awarded the Distinguished Federal Civil Service Award to Dr. Kelsey, who by this time was beginning to make (in retrospect) statements about how she had been concerned with the reproductive safety of thalidomide all along.

However much we all like heroic tales and medals, there is actually very little in the record to bear out the official heroic version of the thalidomide story. Upon careful examination it appears that no reproductive tests were done at all on thalidomide before 1961, nor indeed did the FDA ask for any. In fact, it appears that even had any pre-marketing reproductive tests of thalidomide in rats been done, they would have *still* have shown negative results, for thalidomide (as it turned out later) does not cause birth defects in rats. We now know that it would have taken a much more exhaustive set of animal tests to catch thalidomide than was routinely used anywhere in 1961. An honest reading of the facts thus forces the conclusion that (questions of luck aside) Dr. Kelsey's medal was awarded basically for being a delay-causing bureaucrat and thereby allowing Europeans to serve as first-class "guinea pigs" for Americans, in a case where (quite literally) guinea pigs themselves would not have done an adequate job. Dr. Kelsey's medal was soon to become an excuse for much self-congratulation regarding FDA policy, without much thought being given to what the consequences of a de-facto U.S. marketing delay policy might be, if applied to all new drugs across-the-board.

Read the literature at the time. There were some early reports of teratogenecity but they did not come from the FDA and nor was the FDA concerned with it at the time the application was delayed. Indeed, the thing that really got things in motion was an observation that Dr William McBride (an Australian Obstetrician and Gynaecologist) made in the Lancet.

Regards.

[fritzi93]

Hmm, you seem to be under the impression I'm in clear disagreement. I'm a skeptic. Since you're a doctor and I'm not, I won't debate specifics, nor am I particularly interested anyway. But this argument could just as easily become one on how bureaucracies tend to operate.

I followed the argument about Dr. Kelsey up to the point motivations were attributed to her. At that point it bordered on pure assertion. Furthermore, saying she was using Europeans as "guinea pigs" gets awfully close to sounding like paranoid nonsense. Or maybe someone with an axe to grind.

Sorry, I remain respectfully but obstinately unconvinced.

[northcat_8]

I don't have anything to add to this thread, but I just wanted to say that I wish this thread would drop to page 2.

Because everytime I'm reading down through the topics and I read "WTF is wrong with this world?"

I think to myself "Man, that's a ******* list"

EVERYTIME! it never fails, even when I know I'm going to see it.

[vitualis]

I agree that page probably is somewhat too critical but the facts are:

1. Francis Kelsey did not suspect tetratogenecity at the time the FDA blocked the application for thalidomide.
2. There were some concerns (rightly) that the safety data as per animal studies were flawed and that there was a concern of neuropathy (somewhat a furphy)
3. The FDA did not ask for further animal safety trials in terms of teratogenecity
4. The FDA did not show that thalidomide caused birth defects
5. The FDA was completely uninvolved in the discovery of the terrible side-effects of thalidomide

Now, the later version of events of how Dr Kelsey "suspected" or was "concerned" about the reproductive safety of thalidomide is bollocks. If she suspected it, she made no actions in determining it one way or the other.

She was concerned about some relatively trivial things (at the time) and blocked the application. Now, I'm not saying what she did was wrong. It was right. However, the lesson wasn't learned. Drugs with dodgey or limited animal safety data shouldn't be approved. However, it appears that in the US, this got spun into some sort of American legend of how the FDA discovered the bad side-effects of thalidomide. They didn't. They got lucky in that the application was blocked and in the mean time, OTHER people discovered it's problems and made it known worldwide.

Take a look at rofecoxib (aka Vioxx). The VIGOR trial a few years ago already clearly demonstrated a large increase in MI compared traditional NSAIDs: http://vitualis.blogspot.com/2004/11/vioxx-heart-risks-apparent-for-years.html

Similarly so with celecoxib (aka Celebrex). There was a big upcry recently (about a year ago) when it was discovered that the outcome criteria of the original FDA trial had deliberately been changed to provide results that put celecoxib in a favourable light. The reason anyone would want to use celecoxib over traditional NSAIDs is that they are supposed to be safer from a gastrointestinal perspective. The original trial was to look at the rate of GI bleeding at a year. However, the results that were reported on were only at 6 months -- which showed celecoxib to cause much less GI bleeding than traditional NSAIDs. But if you look at the 1 year data which was the original study design, celecoxib was actually non-significantly WORSE than some traditional NSAIDs (either against ibuprofen or diclofenac -- can't remember).

IMHO, the FDA is at present dysfunctional.

Regards.

[tweedledee]

Then I bust you in the mouth and ask for the scrip back, again. No,a nd I come over the counter. (Well, at my age, maybe come around the counter.) You get my meaning.

Hey George, would you really go to all that trouble for your VIAGRA?

[fritzi93]

Okay, that's a reasoned argument, but I wouldn't pretend to be able to evaluate the facts. I wonder though, why criticise her and not those in comparable positions of authority in other countries who gave it the O.K.? Not to be a wise guy, but I don't have a high regard for ANY bureaucracy. Organizations and the persons in them have their own interests.

So would you say that the approval process is unduly influenced by, uh, non-technical considerations? Happens all the time, the experts get over-ridden by the organization men. NASA is the supreme example. 'Scuse me, off-topic.

Anyway, I heartily agree with Northcat.

[fritzi93]

Then I bust you in the mouth and ask for the scrip back, again. No,a nd I come over the counter. (Well, at my age, maybe come around the counter.) You get my meaning.

Hey George, would you really go to all that trouble for your VIAGRA?

Jeez, I missed that, gotta read more carefully. For shame, George. :P

[gmatov]

Michael,

"Using one of the combination regimes (e.g., in OZ we have something called "Losec Hp 7" which has amoxycillin + clarithromycin + omeprazole) which generally involves combining an antibiotic or two with either a PPI or bismuth leads to eradication rates of over 90%. "

You mean the major druggies have made a version of Prilosec to sell you in place of the antibiotic regimen, plus bismuth, you agreed was the treatment of choice a few posts back?

Shame on yunz. I just hope you get a good junket from prescribing this instead. Fiji, maybe? Means the Aussies may not be immune from "Detail Men" as you try to imply, no? Or is it just simpler to accept what the pusher tells you than to do the reading and research, and maybe suffer opprobrium from your peers as a rebel, one who actually researches the treatments available, prescribes the best and least costly?

And you give hell to Budz for wanting the "latest" antibiotic for his "flu", a virus that no antibiotic can help with, except for possible side infections.

As to Thalidomide, I am and was unaware that it was a hangup in the US FDA that prevented its introduction here till the "flipper babies" were being born.

I am very disappointed in the present Admin that wishes for the FDA to "fast track" new formulations. We constantly hear of the "8 billion bucks to create a new drug". We rarely hear that it is more like a couple hundred million in actual exploratory expenses, billions more to buy off legislators, world wide, and advertise, world wide.

Recent Business Week had the Drug Companies with reduction of researchers of some 2 %, increase in promotion of, I think, 169 %. Ie, billions to promote.

Tweedledee,, if I could afford the co-pay, all it would allow is for me to piss on the wall instead of down toward the pot. Or, I could try standing on my head.

Fritz,

Don't pay him no never mind. He might be older than me and just jealous.

Cheers,

George

[vitualis]

"Using one of the combination regimes (e.g., in OZ we have something called "Losec Hp 7" which has amoxycillin + clarithromycin + omeprazole) which generally involves combining an antibiotic or two with either a PPI or bismuth leads to eradication rates of over 90%. "

You mean the major druggies have made a version of Prilosec to sell you in place of the antibiotic regimen, plus bismuth, you agreed was the treatment of choice a few posts back?

Shame on yunz. I just hope you get a good junket from prescribing this instead. Fiji, maybe? Means the Aussies may not be immune from "Detail Men" as you try to imply, no? Or is it just simpler to accept what the pusher tells you than to do the reading and research, and maybe suffer opprobrium from your peers as a rebel, one who actually researches the treatments available, prescribes the best and least costly?

Um.. okay. I'm not actually too sure what you're talking about here...

As for "Prilosec" I don't know what that is (presumably some sort of US trade name for something not in Oz).

I would use Losec Hp7 because it is a combination treatment... That is, it is THREE drugs. It would be cheaper for the patient to get this one week combination pack than it would be to prescribe the three separately -- not to mention more convenient. It should be noted that amoxycillin, omeprazole and clarithromycin are all off patent so I wouldn't be surprised if there is a generic version of "Losec Hp7". As far as I'm concerned, the pharmacist can give whatever they want as long as it is the same drugs at the same doses.

And you give hell to Budz for wanting the "latest" antibiotic for his "flu", a virus that no antibiotic can help with, except for possible side infections.

There is definitely a push in Oz for good quality primary health care. Giving inappropriate antibiotics is not good quality health care. All good GPs I know would counsel the patient not to take antibiotics for a simple URTI (upper respiratory tract infection) unless it appears to be getting worse or not improving after a few days.

Regards.

[fritzi93]

George, you wouldn't REALLY bust some tight-ass in the mouth over a prescription, wouldja? :P

[ViRaL1]

Climbing over the counter (or even walking around the counter) to kick a pharmacist's ass is totally ridiculous. Just wait for them to get off work then run them down in the parking lot. On the other hand, if your car already has a good bit of body damage anyway. Just say 'I'll be back,' and come crashing through the pharmacy in your rustbucket.

[Capmaster]

George, you wouldn't REALLY bust some tight-ass in the mouth over a prescription, wouldja? :P

Sure. If George wants to get a first-hand account of Pennsylvania's prison system

[ViRaL1]

On the other hand, even though it's just a piece of paper, the prescription IS yours. I'd call the police and tell them someone else had my property in their possession and refused to relinquish it. THEN if that didn't go my way, I'd resort to the Terminator approach, complete with automatic weapons.

[gmatov]

Michael,

Try here http://www.google.com/search?q=prilosec&start=0&start=0&ie=utf-8&oe
=utf-8&client=firefox-a&rls=org.mozilla:en-USfficial

I hate that, I just made the page twice as wide. I don't know if you can cut and paste part 1 and part 2 from =utf-8&clien and make it a URL.

I just split the URL and it may not work.

losec7 sounds like a repackage of Prilosec omeprazole . It will cure you of GERD if you take it for the rest of your life, just as most other medicines will, IF you take them for the rest of your life.

here, it is peddled to the public as "The Purple Pill", aka Nexium..

Are you sure all you get is the straight skinny? Both are peddled by Astra Zenica.You just might be less erudite, as to medication, than you think you are.

Fritzi

Don't pay that old fart no never mind. As far as busting a pharmacist in the mouth, well, yeah, if he stood in the way of my prescription being filled, as written, I do think I would, if they refused to return the original to me. **** 'em if they said no I will not, take it elsewhere, and returned it.

PA prison system. We got a Capmaster to make sure we don't get too far out of line.

I will, here and now, register the first Nay to his appointment as Moderator.

I have been here and there, and do not feel he is worthy of the appointment. Should you be the Arbiter of whether you should or should not be, so be it. I simply do not like you. And that is not easy to decide online.

I think you are a jerk.

So, ban me if you like.

Cheers,

George

[tweedledee]

For Chriiiiist sake George, calm down!!!!!!! You've threatened every chemist in the US, you've called Capman a jerk, and me an "old fart", you've got yourself as excited as a blind lesbian in a fish shop, and for what???????. You'll still be able to get your Viagra and Prozac, so don't panic. As a matter of fact, have a Prozac and a cuppa tea and the world will seem better.

Merry Christmas

[fritzi93]

Ow! C'mon, admit it, you'd miss George if he left, things get boring here from time to time as it is. I just love those spicy posts. (Hope Cap has a thick skin, though).

Hey George, personally, I think it musta been blood pressure medication you were after, not Viagra. Careful there, be well. :P

[Capmaster]

Ow! C'mon, admit it, you'd miss George if he left, things get boring here from time to time as it is. I just love those spicy posts. (Hope Cap has a thick skin, though).

Hey George, personally, I think it musta been blood pressure medication you were after, not Viagra. Careful there, be well. :P

Nooo ...it doesn't bother me But ...George is George after all ...mad at the world because he's George. Must suck to be you :P

He's just irritated because I keep catching his mistakes when he makes bald-faced statements, like "there are no "little" bombs, referring to nukes over at Politick, and his statement earlier in this thread saying Prilosec and Nexium are the same thing. They're not, George.Prilosec is Omeprazole and Nexium is Esomeprazole magnesium

My mom had a saying that George should remember: "Make sure the brain is engaged before putting the mouth in gear"

[fritzi93]

Okay, hope I didn't start something that will result in any hard feelings. Just joking, and it's always meant in a friendly way. Think I'll slink over to the STFU thread now, looks like fun.

[Capmaster]

Okay, hope I didn't start something that will result in any hard feelings. Just joking, and it's always meant in a friendly way. Think I'll slink over to the STFU thread now, looks like fun.

Not to worry. This isn't a flame war. Cappie don't do that no mo

[ViRaL1]

Looks like this is when the REAL fun starts. :P

[Capmaster]

George is entitled to his opinions, and I'll be the first to defend that. We maybe don't see eye to eye, but I have nothing personal against George, in spite of his feelings to the contrary. I disagree with many of his posts, and I've called him on it. I think that's what sets him off. Kinda childish, but that's his problem, not mine He seems to dispute my value as a moderator because I disagree with him on many things. Guess George sees himself as perfect and beyond question. Again, that's his issue

The place would be less interesting without George. And much as he'd like to be a martyr by being banned, he's done nothing to deserve that.