Where is this dude? I asked him what a failed trial was and he disappeared off the earth.
My guess: He doesn’t work for a drug company at all. He was just trolling.
If he was maybe he couldn’t say anything else without looking really bad?
I know, maybe he was a scientologist, trying to make all of you non paranoid delusionaries look bad, by being a fake.
One lesson you need to learn: You don’t have to be a Sc. to find deep systemic problems in the prescribing of psychiatric medications.
Reported this thread to a moderator to ask it be closed. The original question has been answered multiple times.
You are out of line.
If you wish to open a thread challenging the pharmaceutical industry, you may do so.
You MAY NOT hijack this thread into a rant against that industry and you absolutely may not do so by making personal attacks against another poster.
If you try this again, you will receive a Warning.
I am not going to close this thread as there may be other posters who wish to comment on the actual topic, but any further attempts at a hijack will not be permitted.
[ /Moderating ]
ISTM that’s been a fairly common way to make point-by-point responses. Well, not all that common maybe, but hardly unheard of.
Theres a lot of research at the moment attempting to find faster acting anti-depressants that don’t have the more normal 2-3 week lead time to obtain full effect.
Ketamine has been found to be effective within hours , eg pronounced effect within 24 hours.
Another new drug currently under trials has similar properties:
Tom and Deb:
Where were you when I was being attacked previously? What is your reasoning?
My father was a doctor who was sometimes involved in drug trials. All of his “failed trials” were cases where the drug didn’t work, or didn’t work as well as treatments already on the market. And they tended to be followed closely by stock prices dropping. (Small drug companies.) So whether they were published in journals or not, the negative results of those trials seemed to make it out to the part of the public that cared.
Mostly that you seem to think psychiatric doctors are a different species from other doctors. They get the same training at the same medical schools.
That you have a weird notion that testing standards are different for psychiatric drugs than for other drugs.
That the psychiatric industry is out to get us, and the various practitioners in it completely disregard the interests of patients.
Nope. I wouldn’t have thought it odd if he just disregarded the accusations that he is a Scientologist, or said outright that it is none of our business and he won’t discuss it. But all the odd sidelong comments about “I don’t like being called that” without ever answering the question seem extremely unusual.
Yes, they do. I don’t need insulin, so I’ve never had both prescribed by the same doctor. But my GP, who prescribes my omeprazole and antibiotics, is the guy who prescribed Prozac. And if I needed insulin, he would have prescribed that, too.
As I mentioned above, when he prescribed Prozac he also recommended a good pschologist, who also treated my emotional issues, but who isn’t a doctor and can’t write scrips.
That’s pretty much how most people take NSAIDS (ibuprofin and the like) and cough syrup and other OTC medications. For that matter, that’s how some of my friends have been treated for cancer – “let’s try this chemotherapy and then do a lot of tests to see how it’s working, and after we look at the test, we will increase you dose, decrease it, or put you on a different treatment altogether.”
Every person is different, and we react differently to the same drugs. Good doctors don’t just give you a “standard dose”, they watch how the drug is interacting with your body and its problems, and adjust as needed.
Well who evaluates your SSRIs performance? Your GP? How is he going to make adjustments as time goes on and deal with crises if they occur? Does he prescribe benzos? His choice, or he cannot?
Do you really know how your fathers studies were disseminated? Your statement is too vague to judge whether you know what you claim to.
Do you think the testing standards and methods are the same for a depression treatment as for a cancer treatment? How do you get that conclusion? For the child of a Dr you seem to be woefully uninformed.
If a failed trial is one where it didn’t work like you wanted and you keep it from being reported that is corrupt. You need to include all your data to get a fair appraisal of a drug. It may happen with non psych drugs. Please don’t twist my words. What is the “weird notion”?
Psych Drs are psych Drs. They are distinctive in the issues they deal with, in their treatments, and they do have their own professional organization, which your other Drs are not members of I would venture. Did I say anything beyond that that you could find erroneous? What is that? If GPs prescribe both insulin and SSRIs that’s OK. My statement was in context of responding to someone here. Doesn’t change my meaning or the industry. Why bother picking scabs?
You said: “But all the odd sidelong comments about “I don’t like being called that” without ever answering the question seem extremely unusual.”
This is a very queer statement. Many people here seem to be fixated on me being a scientologist. Not my problem. You think that’s strange, have at it. Why would you need me to be one? If I already said I wasn’t it seems really rude to feed it over and over again. though. By the way, when did you stop being a candy stealer?
You are determined to gloss over all distinctions in specialties and medicines, and attacking the integrity of anyone who documents otherwise. You are behaving as people in a cult behave.
You can twist it any way you want. I am pointing out objective journalism that indicates the industry doesn’t work the way you would have it. Are you going to say I’m to blame for that?
http://ethics.harvard.edu/pharmaceutical-industry-institutional-corruption-and-public-health
http://www.cnbc.com/id/41257952
Please let me know if any of these is a scientology front group and I will remove it.
In the mean time, if someone is going to respond, would you please read the links and be prepared to discuss the contents instead of calling me paranoid, delusional or a scientologist. Is that too much to ask on straight dope? Or is that the reason they call it dope?
Of course he can prescribe benzos. Why the hell should he prescribe them for depression? Can you please drop the distraction of benzos? I thought this was a thread about SSRIs and closely related drugs.
Anyhow, I evaluated my SSRI performance. Who else has the data? I never had any “crises”, and “crises” are not a common result of taking SSRIs. I emailed my doctor with detailed descriptions of the effects of the drugs and the side effects, how I had adjusted my dose in response to that, and he offered additional suggestions and feedback. Obviously, I needed to have his blessing to make any long-term changes to the dosing, but if you start with a supply good for a few months, it’s pretty easy to adjust your own dose short-term.
Okay, you are wrong again. I said the stock price of publicly traded companies dropped when a study failed to find the drug worked. It is completely irrelevant how those results were disseminated, as they obviously were. He used to talk about the correlation between study results and stock prices fairly often, as playing the market was one of his hobbies. He wasn’t allowed to invest in companies that he was testing for (there are securities laws against taking advantage of private information) but he sometimes invested in drug companies when he had read public-but-obscure information about the drugs they were developing.
Yes. I used to read the New England Journal of Medicine back when it was knocking around the house, and I have a pretty good idea of how drugs are tested. That’s something you seem to have been misinformed on.
I had no idea scientolgists had any interest in SSRIs until this thread. Not my fight. And I even wrote a PM to one guy who seemed overly aggressive in accusing you of being a scientoligist to tell him that (that his tone seemed aggressive to me.) But your response has surprised me.
Good call about stealing candy by the way! I used to sneak chocolate chips out of the bag in my mother’s pantry, which pissed her off, because then the bag would be short when she wanted to use it. I stopped stealing candy when I acquired enough income to buy my own candy, and was no longer tempted to take it from my parent’s cupboard. 
Oh, and I’m not going to read all your links. Sorry. I actually have a lot of second-hand knowledge of how drugs are tested, and did a lot of research specifically into SSRIs before I took any. I really have no interest in reading a bunch of scare journalism. If there’s some succinct point they make that you want to repeat I may read that. But the points you’ve made so far are, shall we say, extrmely unpersuasive.
The only thing you’ve said that is right is that the drug companies are trying to make money. But I have no clue why you think this is a more serious problem for SSRIs than for statins.
Since it seems too difficult for everyone to play nice, I am going to go head and close this, after all.
I am going to respond to a request to re-open this thread.
HOWEVER, any comment directed at another poster that questions or challenges their honesty, intelligence, sanity, sincerity, or belief system will receive a Warning.
Stick to the specific topic of the actions of the medical, psychiatric, and pharmaceutical industries, supported by evidence, without making any assumptions or claims regarding the posters in this thread.
This includes refraining from quoting earlier posts for the purpose of continuing a feud or making broad-based accusations against posters as a group.
[ /Moderating ]
First, thanks to tomndebb for re-opening the thread. I politely hope everyone can get along or at least pretend to, so I don’t look stupid for requesting the re-open.
I’m here. 
I’m not really sure what happened to my weekend but I’ve been mostly away from the computer. Apologies for dropping the ball. That said, others have answered what I did not: a “failed trial” is one that doesn’t achieve its pre-specified objectives, whatever they are.
Anyway:
AND
Disclaimer: I have not, myself, ever worked directly on a mental health trial. My therapeutic area is different (one you would probably call “physical” medicine). I have, however, read dozens upon dozens of journal articles and study reports across the specialties, and I’m fairly familiar with most of them.
Critically: **There are very few meaningful differences between a psychiatric drug and any other drug in terms of how it is tested, evaluated, and approved. **
They all start the same: in a laboratory somewhere, where chemists hypothesize that if they can do X, it might have beneficial effect Y. They develop their drug and test it without living subjects, and then using mice or dogs or monkeys - trying to see whether they’re getting the chemical reactions they want and whether they’re hurting the test subjects. One difference with drugs for depression manifests at this stage - animal testing is a little less useful to establish efficacy. You can tell whether your drug is lowering Templeton the rat’s cholesterol, but not whether Templeton feels less social anxiety, right?
In any case, once you have a candidate drug - again, this applies across every field of medicine - you’re going to petition the FDA to let you give your drug to human patients (you’ll also have to petition the regulatory authorities of any other country where you want to test, but let’s keep this simple). You’ll send literally everything you have to FDA. They’ll inspect your manufacturing sites, review every shred of data you’ve ever produced, and then they’ll give you a go-ahead.
You’ll conduct a Phase 1 study. This will be a safety study, with a small number of patients. You won’t be able to tell if the drug works from this study - there will be too few patients. You might be able to get a sense of the general trend, but what you really want to be sure of is that your drug isn’t going to kill people or make them grow a third arm. FDA will approve the design of this study.
If this works, you’ll seek permission to initiate a Phase 2 study (and eventually an even larger Phase 3 study), with more patients. In this study, you’re going to start establishing the benefits of your drug. You’ll enroll more patients. You might compare patients who receive your drug with patients receiving no treatment, or a placebo, or another drug. Before you even start the study, you will agree with FDA on the goal of the study. For a cancer drug, it might be survival (how long the patient lives). For depression, you will identify one or more validated instruments for measuring depression. You’ll see if the patients getting your drug have better scores on those instruments over time than patients who do not… but “better” won’t be good enough. You’ll identify - again, this is before anyone ever gets a dose! - how much better they have to do in order to be statistically significant (which ultimately just means that the patients getting your drug have to do so much better that it’s not likely to be the result of chance). The statistical measures here don’t care if you’re treating heart disease or lupus or rabies or anxiety or depression - they are absolute and objective.
Now you conduct your studies. A drug company will typically work with one (or more) external investigators, physicians at academic institutions or hospitals who actually conduct the trial, treat and evaluate the patients, and record the results. For Phase 2 and Phase 3 trials, even the investigators are often blinded - that is, they don’t know which patients are getting the investigational drug and which are not (this keeps them from being biased in favor of your drug).
Now remember, you’ve been in consultation with FDA all the way. They know you conducted this study. You are supplying them regular safety reports. When the trial is done, if you achieve your goal: GREAT! You write up a detailed report and send it to FDA. You announce the results via press release. Then you submit a marketing application to FDA including the full study results, plus all the results of everything you’ve ever done with this drug. They look at it and - if they think the benefit you’ve shown outweighs whatever risk you’ve shown - they will approve the drug to be sold.
If your trial fails? You still write the report. You still make the announcement via press release. And then, guess what: you don’t give the drug to patients ever again (at least, not for that condition).
I can’t emphasize this enough: there are no shadow clinical trials, secreted away from the public eye, that secretly show that marketed drugs are ineffective. I cannot even fathom how such a thing could happen!
Now, look. The industry - like every industry - has problems. There is corruption; there are greedy people and unethical people, and greedy unethical people. There is also incompetence. I do not want to minimize the importance of these things. Every person in the pharma industry who is ethical - and I can tell you, whether you believe me or not, that 95% or more are - despises the cheats and the frauds as much as or more than you do. But the things I believe most strongly are these:
The vast majority of people working in the drug industry, including nearly all the doctors and researchers, genuinely want to help people, and work honestly and diligently to do this. We all want to make money, too - I assume you also want to make money doing whatever your job is! - but the attraction of producing usable science is part of the compensation, as well.
To the extent that corruption, incompetence, etc, are a problem, they are not a problem unique to psychiatric medications. There is nothing about Zyprexa or Lexapro that makes them especially susceptible to these things compared to Gemzar or Nexium.
Thank for you the excellent info storyteller0910, very informative.
Story teller said “There are very few meaningful differences between a psychiatric drug and any other drug in terms of how it is tested, evaluated, and approved.”
How could this be true?
A psychiatric drug is directed at behavioral, and experiential problems. Other drugs are against viruses, bacteria, organic pathologies, or pain etc.
Psych drugs are aimed at DSM listed conditions, other drugs are not. The DSM changes with societal preferences and the prevailing models of mental health as defined by Drs, and Industry.
There is good reason to be skeptical of a model of mental health that keeps roping in people (Esp children) and conditions in an expanding manner to be pathological and that defines each pathology to be one which should be medicated with a drug.
The guessing game of what to prescribe and how much and when and how to cross to another is not benign, when it concerns people who are suffering mentally.
No, Depression has existed long before the DSM existed. We have reports of sufferers from it from Ancient Greece and Rome.
http://www.gulfbend.org/poc/view_doc.php?&id=12995&cn=5
OK, let me turn this around on you, if I may: in what way, specifically, do you think it is not true? I’ve just outlined the clinical trial process; at which stage do you think there are differences? What do you think those differences are?
It’s funny you mention pain, because pain is no less experiential than depression or anxiety. You can’t “prove” pain with an objective laboratory test, so the only way to find out if someone has it, or how significant it is, is to ask them. And yet no one doubts that pain is real nor that the drugs that treat it have value. I suspect that this is because every person has direct experience with pain, but not with mental health problems.
http://www.wayneramsay.com/drugs.htm
[Excess copyright violation clipped.]
I do this because I love you. See you next week.
I don’t even know where to begin. Basically everything in those two posts is either false or misleading. It’d take me all night to unpack.