Psycho-Babble Medication Thread 735309

Shown: posts 1 to 25 of 62. This is the beginning of the thread.

 

Robert Whitaker and Zyprexa (trigger)

Posted by Squiggles on February 23, 2007, at 7:06:09

Some posts ago, someone said i should take a look at what Robert Whitaker has to say about the antipsychotic drug, Zyprexa. Well, i looked and found a couple of articles under:

http://www.thestreetspirit.org/August2005/interview.htm

http://zmagsite.zmag.org/May2004/levine0504.html

I'd like to add that Robert Whitaker is a member of Mindfreedom and takes a radical perspective on the mistreatment of patients by pharmaceutical companies. He is a prize-winning journalist (author of "Mad in America"). Personally, I don't have enough evidence or knowledge to believe that drug companies are more likely to mistreat the mentally ill through drugs, than hospitals or physicians or psychiatrists. In all cases, the rule of law is the best watchdog. Somebody said "if they won't do the right thing, make them".

Squiggles

 

Re: Robert Whitaker and Zyprexa (trigger) » Squiggles

Posted by Phillipa on February 23, 2007, at 11:28:08

In reply to Robert Whitaker and Zyprexa (trigger), posted by Squiggles on February 23, 2007, at 7:06:09

Squiggles all I know is the girl across the street is on medicaid staying with her folks and they put her on zyprexa. But why do so many here say zyprexa will stop anxiety in a heartbeat very quickly? Love Phillipa

 

Re: Robert Whitaker and Zyprexa (trigger)

Posted by Squiggles on February 23, 2007, at 11:33:00

In reply to Re: Robert Whitaker and Zyprexa (trigger) » Squiggles, posted by Phillipa on February 23, 2007, at 11:28:08

I don't know. I guess, someone has to
keep track of the many and the few and
their different biological or life situations that
may play a role on how they respond to the med.

Squiggles

 

Am I the only person bothered by these articles???

Posted by UgottaHaveHope on February 23, 2007, at 11:36:08

In reply to Robert Whitaker and Zyprexa (trigger), posted by Squiggles on February 23, 2007, at 7:06:09

Wow, they blow my mind, especially the first one. Is all of that true? If so, man ....

 

Robert Whitaker

Posted by med_empowered on February 23, 2007, at 13:37:38

In reply to Am I the only person bothered by these articles???, posted by UgottaHaveHope on February 23, 2007, at 11:36:08

I've been a fan of Whitaker ever since "Mad In America"

Now, he's considered a "radical," but that's just because of where his research led him. As I understand the story, here's what happened: he was working for the Boston Globe, and he was to do a series of papers on the progress in the treatment of schizophrenia. He thought it would end up being old drugs=bad, new drugs=miraculous, but then he actually did the research and...it didn't turn up anything like that. I read "Mad In America" and I think everyone should; psychiatric patients, psychiatrists, psychologists, people who know someone who is "mentally ill"....
what's disturbing about Whitaker's opinions and research isn't their harsh tone--its that their harsh tone is very well-supported by decades upon decades of research. He's anti-neuroleptics because he's one of the few researchers to look at the issue from an unbiased, objective viewpoint and arrive at the conclusion: neuroleptics are very, very bad drugs. It isn't anti-psychiatrics propaganda. When I read the book, I thoroughly re-researched his data, thinking I'd fine misrepresentations or something like that--NOTHING. He's dead on accurate when he says neuroleptics shut down higher brain functions and are more a way to quiet people than to help them.

 

Re: Robert Whitaker

Posted by Squiggles on February 23, 2007, at 13:59:45

In reply to Robert Whitaker, posted by med_empowered on February 23, 2007, at 13:37:38

To give the devil his due, i just came across a warning from Health Canada (it seems i get one
every day now):


"Health Canada is advising consumers not to use a product called
Sleepees, because it was found to contain an undeclared drug
estazolam, which can be habit-forming when used for as little as a
few months. Consumers who may still have this product in their
homes are advised to consult with a health care professional
before they stop taking the capsules, because of the risk of
withdrawal symptoms."

I looked up this "herbal" sleep/weight loss medication for its effective ingredient and found that it is a benzodiazepine. I don't think benzodiazepines are herbs, so maybe they just threw in some mint leaves to make it look "natural".

So, the point is that these herbal companies that are competing with BigPharma, are no more conscientious in their marketing practice; though i grant that there is a big difference between benzos and neuroleptics.

As I said, "rule of law";

Squiggles

 

Re: Looking for the Middle Ground Here

Posted by Joe Bloe on February 23, 2007, at 16:29:13

In reply to Re: Robert Whitaker, posted by Squiggles on February 23, 2007, at 13:59:45

This discussion on drugs is so multi-faceted and so difficult.

I am starting to think that reports such as Whitaker's are mostly true, but that the anti-med theses they form from their evidence can be a little extreme (not saying that Whitaker is outright anti-med, I haven't read more than one article just a minute ago). On the other hand, the drug companies are just as one-sided and extreme in their lust for profit.

To the anti-med crowd: I saw my grandfather (D. 1989) while growing up, who in retrospect, definitely suffered from pretty terrible MDD for as long as I saw him. My father told me that my great-grandfather suffered from a similar condition. It hurts me to remember seeing my grandfather miserable for most of the time I saw him alive and that today he might be able to find some relief from this. He was a very, very intelligent individual, but overcome by melancholy. I am almost certain that he could have lived a better life had he been on a little medicine.

On the other hand, meds do seem like they can be outright bad for you and that they might even have irreversible side effects. The drug companies are definitely involved with questionable to downright shady tactics to market drugs and to keep people thinking they are safe wonder drugs. The drug companies represent the flip side to the anti-med crowd: "these drugs are good for you, they correct natural imbalances, they are virtually harmless."

I am trying to find a middle ground here. On one hand, this involves recognizing that pharma companies lie and are giving a totally narrow view of their product to the public to increase sales. They are like a used car dealer who has a car on his lot with some engine and transmission problems, but who tries to sell it to the buyer as a product in perfect running condition. Like this used car dealer, their goal is sales (for profit), which can help explain why they spend 3 times more on marketing than R&D, (and of course, R&D is important to replenish your marketing department with drugs to market, just like the used car dealer needs cars to sell).

On the other hand, drugs can really improve the lives of SOME individuals in profound ways. They have improved my life to a reasonable extent.

 

Re: Looking for the Middle Ground Here

Posted by Squiggles on February 23, 2007, at 16:52:54

In reply to Re: Looking for the Middle Ground Here, posted by Joe Bloe on February 23, 2007, at 16:29:13

I think each case merits its own investigation.
Its human nature to generalize in order to make
sense of the world and imbue these issues with
meaning.

Sorry about your grandfather-- who knows what
drugs he would have gotten though; sometimes people self-medicate with alcohol.


Squiggles

 

Re: Looking for the Middle Ground Here

Posted by med_empowered on February 23, 2007, at 23:02:35

In reply to Re: Looking for the Middle Ground Here, posted by Squiggles on February 23, 2007, at 16:52:54

The drugs can help some people. But...alcohol, opiates, amphetamines, cocaine, ketamine, shrooms, and other drugs can also help people, often with fewer side effects and more immediate results than newer, "safe" pharmies. Why should the government give prozac thumbs up but continue to punish people who possess/sell pot (or coke, heroin, etc.) ? I'm certainly not saying that human misery can't be reduced by drugs; I'm saying we should have open access to all these drugs and then make up our mind. Something tells me that if we were all able to legally purchase pot and opiates, Prozac and other ADs (and DEFINITELY the antipsychotics) would lose a whole lot of popularity.

 

Re: Looking for the Middle Ground Here

Posted by Squiggles on February 24, 2007, at 7:21:00

In reply to Re: Looking for the Middle Ground Here, posted by med_empowered on February 23, 2007, at 23:02:35

I agree with that. The drugs that
are presently available are mostly more
unpleasant than illegal drugs. But that
all drugs made by big drug companies are
bad, simply on the grounds that the motive
for making them is profit, is just not true
for all of them.

Squiggles

 

Re: Looking for the Middle Ground Here

Posted by Sebastian on February 25, 2007, at 15:30:02

In reply to Re: Looking for the Middle Ground Here, posted by Joe Bloe on February 23, 2007, at 16:29:13

Drugs may do all that, but I don't think they arn't harmfull. So far no bad effects from abilify, but I worry there may be, .. How long before we know.

 

Drug manufacturing and quality control

Posted by Squiggles on February 25, 2007, at 17:21:34

In reply to Re: Looking for the Middle Ground Here, posted by Sebastian on February 25, 2007, at 15:30:02

I was just searching to see if there is
another brand of imipramine, than "Apo-imipramine".
There is another "Novo-imipramine", which is the same price, and "Tofranil" (the original trade name of the drug), which is about twice the price.

The reason I ask is because one factor that has not been considered in this case of ineffective imipramine, is the possibility that the manufacture of drugs varies according to origin of country or lab, or company. I know this was the case with lithium, when I reached sub-therapeutic levels and fell into mixed states. When I changed the brand to my old one, I recovered from a dangerous condition.

Does anyone know about the possible variability of quality control in drugs?

Maybe this is the reason 300mg imipramine is required and is still weak (not my case).

thanks for any tips you may have;

Squiggles

 

Re: Drug manufacturing and quality control » Squiggles

Posted by laima on February 25, 2007, at 23:14:08

In reply to Drug manufacturing and quality control, posted by Squiggles on February 25, 2007, at 17:21:34


Yes, a little- my doctor consults on some drug trials and had much to say about how the fda holds generics to much lower level of scrutiny than brand name. Generics also are officially allowed to take certain measures to reduce their costs: ie, use different quality or amount of raw ingredients, and are not subjected to loads of tests and inspections. He didn't blink an eye or utter any disagreement at all when I suggested brand and generic adderall are not the same. Rather- "There could be many reasons contributing to that...many patients feel the same..." I wrote about it in one of my adderall threads. Apparently, fda is stretched thin, and more concerned with establishing safety or efficacy of new drugs, and slacks off considerably with generics. Sounds like as long as they are in the ballpark and the factory is sanitary- they are good to go. A couple months ago there was a thread here on babble about how generics are allowed by law a 20% give or take in difference from brand name. Pharmacists love to deny this, but personal experience begs to differ, and I'm thrilled that my doctor not only didn't deny it, but offered explanaitions.

Think- fda can't even keep track of spinach or peanut butter quality!


> Does anyone know about the possible variability of quality control in drugs?
>
> Maybe this is the reason 300mg imipramine is required and is still weak (not my case).
>
> thanks for any tips you may have;
>
> Squiggles

 

Re: Drug manufacturing and quality control

Posted by notfred on February 26, 2007, at 1:19:56

In reply to Drug manufacturing and quality control, posted by Squiggles on February 25, 2007, at 17:21:34

>
> Does anyone know about the possible variability of quality control in drugs?
>


My understanding is that the variation is in bioavailability as generics must prove that they are bioequivalent to the brand. Bioavailability
is about how well the body takes up the med. This is where the inactive ingredients come into play and manufacturing process can also matter.

 

Re: Drug manufacturing and quality control

Posted by Squiggles on February 26, 2007, at 6:15:04

In reply to Re: Drug manufacturing and quality control » Squiggles, posted by laima on February 25, 2007, at 23:14:08

Thank you laima and notfred. I am suggesting
to my friend that she switch to Tofranol, and
not the generics; the problem may be that it
is not made *anymore*, and all that there is, is
generics-- these old drugs like lithium and imipramine may also not get the white glove treatment. But, I think that given the switch to a generic at around the same time that depression arose and other unexplained symptoms, it's worth checking with the pharamacist.

I don't mind generics in electronics and shoes (or knock-offs as they are called in the new market), but when it comes to health products, we are in trouble.

Thanks again for your input.

Squiggles

 

Re: Robert Whitaker and Zyprexa (trigger)

Posted by ralphrost on February 26, 2007, at 6:52:56

In reply to Robert Whitaker and Zyprexa (trigger), posted by Squiggles on February 23, 2007, at 7:06:09

Freaking true and sad...

> Some posts ago, someone said i should take a look at what Robert Whitaker has to say about the antipsychotic drug, Zyprexa. Well, i looked and found a couple of articles under:
>
> http://www.thestreetspirit.org/August2005/interview.htm
>
> http://zmagsite.zmag.org/May2004/levine0504.html
>
> I'd like to add that Robert Whitaker is a member of Mindfreedom and takes a radical perspective on the mistreatment of patients by pharmaceutical companies. He is a prize-winning journalist (author of "Mad in America"). Personally, I don't have enough evidence or knowledge to believe that drug companies are more likely to mistreat the mentally ill through drugs, than hospitals or physicians or psychiatrists. In all cases, the rule of law is the best watchdog. Somebody said "if they won't do the right thing, make them".
>
> Squiggles
>
>

 

Re: Drug manufacturing and quality control » notfred

Posted by laima on February 26, 2007, at 8:56:53

In reply to Re: Drug manufacturing and quality control, posted by notfred on February 26, 2007, at 1:19:56


Yes- I am certain manufacturing processes and other such factors must play a role. But I feel I heard the part about how they "might" in some cases use lower quality or "less pure" raw ingredients from a pretty credible source. My doctor specializes in pharmacology, and has been involved as an independent consultant for some drug studies, so knows some stuff about fda regulations and industry rumours, etc. I should be clear- he never said anything like, "generics use poor quality ingredients"- but believes it's a definate indirect possibility. (He also has no grudge against generics, and prescribes them regularly--but acknowledges that some people do detect a difference of action in some cases, and in those cases, he specifically prescribes for them the version that works better for them.) Generics get to cut costs- fda gives them permission to take measures to do this---quality of ingredients are a way of cutting costs. I mean, isn't 99cent generic supermarket butter bio-equivalent to 6$ organic guormet Danish butter? But they don't taste the same. Isn't Maxwell House coffee technically bioequivalent to Starbucks, of same varietal? But they don't taste the same, and in processing, the darker the roast, the less caffeine. Well, I don't know if these are very good analogies, but I'm not thinking of a better ones off the top of my head. I also personally note that if the fda is failing at monitoring spinach and peanut butter quality- why should I think they are closely watching what the generics are doing, unless someone complains? I picture some inspector showing up time to time to see if the place is clean and the pills are still fit for human consumption. Generics are not advertising anything- so there isn't any need to bust them for false advertising. The brand versions already supposedly proved safety...and jumped through hoops to groom their product to perfection in order to sell well and gain a following--and their products are more visible and available for scrutiny by govt and public alike. I'm sure monitoring claims in their advertisements keep the fda pretty busy...I am also sure that each generic manufacturer is different as to their ethics, their choices of how to cut costs, perhaps they use different suppliers for their raw materials, and I bet it varies from med to med. Bottom line: they have permission to cut costs, and are not under the same level of fda scrutiny as are brand name versions.

The single solitary med I ever noticed a quality/action difference for between brand and generic is in the case of Barr adderall-and it was NOT a matter of potency. If Shire brand consistently felt smooth, calm, and bright-with no noticible kick-in or crash, but had modest appetite suppression effect--and Barr generic sent me through a jittery, heart-poundy phase as it suddenly "kicked in", (particularly if I hadn't eaten), had zero appetite effect, was distinctly noticeable when it wore off- and even made me feel emotionally vulnerable at that phase- and eventually just made me plain depressed no matter what the time of day---how can they be bioequivalent? One brightened my mood significantly and didn't ever feel like being on anything, the other was choppy and made me very depressed after two weeks. Like two different drugs. Adderall was designed by Shire to be smooth--and in my case it lived up to the promise quite impressively--so if the generic version loses that key quality thanks to their manufacturing techniques or "inactive fillers"--it's not the same!

And what of that thread from a while ago, where it was reported that generics can be 20% less effective than brand, legally?

> My understanding is that the variation is in bioavailability as generics must prove that they are bioequivalent to the brand. Bioavailability
> is about how well the body takes up the med. This is where the inactive ingredients come into play and manufacturing process can also matter.
>
>

 

Re: Drug manufacturing and quality control » Squiggles

Posted by laima on February 26, 2007, at 9:27:03

In reply to Re: Drug manufacturing and quality control, posted by Squiggles on February 26, 2007, at 6:15:04


Hi Squiggles,

I think it varies med to med, and from manufacturer to manufacturer. What cost cutting measures are they employing, who are their suppliers, are they using different "inactive ingredients", are the "inactive ingredients" REALLY inactive, and do they affect absorption? Maybe even it matters how complicated or simple the medication is. I've been perfectly happy with every single generic I've ever had, with that glaring exception of Barr adderall. However, the original's a very designed drug- so maybe it gives more opportunities for something to go "off", if production ingredients and methods are not followed EXACTLY? (Just my theory.)

And truely- yes, my psychiatrist does consult with some drug trials for brand name drugs, but he regularly checks "may substitute" on scripts and has nothing at all against generics. Just acknowledges readily, when asked, that they CAN be different in some cases, for some patients. And can offer concrete reasons as to why they can be different, while also noting that while the differences may be a big deal to some, others can't detect. I think that's a pretty balanced and reasonable position.

I guess my pet peeve is pharmacists and insurance companies who insist that there are NO differences between brand and generics, EVER- when clearly that hasn't been my experience with this med. I appreciate getting this validation about experiencing a difference, and gaining some insight as to "why"-and it's not "all in my head". I'll be amazed and impressed if your friend's pharmacist acknowledges that the switch to generic could be a reason for your friend's worsened depression. Well, when I asked if generics and brand are pretty much the same, an assistant at my pharmacy rolled her eyes and sarcastically said, "Supposedly! Funny how so many patients want brand when it comes to adderall, and so we are always out." She was on her 10th call to other pharmacies in search of brand adderall-and then the pharmacist walked in, boomed, "THEY'RE EXACTLY THE SAME YOU WANT IT OR NOT?" I regretted giving in, and she got in trouble, I guess for not going along with the Walgreens company mantra.

Another idea for your friend- if her med is no longer available anywhere in the version she's done well on- and the generic she tried didn't work out- maybe it's still worth trying some different brands of generic? There could be a difference- certainly they are not all manufacturing in the same way. I saw an interesting chart on an ADD/ADHD site, where the posters voted for their favorite version of adderall IR. There was the Shire brand, and something like 8 generics, and there was a very wide difference of popularity between the various generics. (Shire got 26% of the vote, and the least popular generics looked to be Barr and Ranboxy. One of the generics listed was almost as popular as Shire. Gosh, hope I bookmarked that page...) Very interesting.

Good luck to you guys!


> Thank you laima and notfred. I am suggesting
> to my friend that she switch to Tofranol, and
> not the generics; the problem may be that it
> is not made *anymore*, and all that there is, is
> generics-- these old drugs like lithium and imipramine may also not get the white glove treatment. But, I think that given the switch to a generic at around the same time that depression arose and other unexplained symptoms, it's worth checking with the pharamacist.
>
> I don't mind generics in electronics and shoes (or knock-offs as they are called in the new market), but when it comes to health products, we are in trouble.
>
> Thanks again for your input.
>
> Squiggles

 

Re: Drug manufacturing and quality control

Posted by Squiggles on February 26, 2007, at 9:43:10

In reply to Re: Drug manufacturing and quality control » Squiggles, posted by laima on February 26, 2007, at 9:27:03

Thanks laima,

I don't want to open up a *HUUUUGE* debate on the status of generics and WHO and the FDA, and the patent protection issues.

Like you, i have not had too much trouble with generics (with the exception of lithium which almost killed me); i did notice that clonazepam in generic form was weaker-- but that's it over a couple of decades.

I agree with you that i could be many factors -- it could that the drug is old, or the lab did not use the same ratio of filler and active ingredients, etc.

So, definitely it is a good idea to switch to another generic just in case. Unfortunately, this issue divides on political grounds and ideology. Well, i think it's a good idea anyway.
Chacun a son gout.


Thanks

Squiggles

 

Re: Drug manufacturing and quality control » Squiggles

Posted by laima on February 26, 2007, at 10:11:41

In reply to Re: Drug manufacturing and quality control, posted by Squiggles on February 26, 2007, at 9:43:10


Yes, I guess you are right.

I confess I've been a bit obsessed with the topic this weekend because of my own personal freak out over discovering that the manufacturer of my least helpful generic, a generic which actually ended up harming my mood, just took over the brand version of a med which worked out very, very well for me, and I'm quite scared right now that they will change it and my mood will go back into the toilet as a result. I haven't had an easy time finding a med combo that actually works for me. Feeling very aprehensive about all this, and feeling upset that the numerous pharmacies I went to in search of my preferred product have been scoffing, even sarcastically, at my concerns, and even at the notion that a difference could exist. It's quite a feeling to have people insist one's experience is imaginary. I guess time will tell how it all works out now with the change.


 

Re: Drug manufacturing and quality control

Posted by notfred on February 26, 2007, at 11:27:39

In reply to Re: Drug manufacturing and quality control » notfred, posted by laima on February 26, 2007, at 8:56:53

Note there is no mention of bioavailability of the brand vs. generic.

http://en.wikipedia.org/wiki/Generic_drug

A generic drug (pl. generic drugs, short: generics) is a drug which is bioequivalent to a brand name drug with respect to pharmacokinetic and pharmacodynamic properties. These drugs are usually sold at a lower price than the brand name drug. Generic medicines must contain the same active ingredient at the same strength as the "innovator" brand, be bioequivalent, and are required to meet the same pharmacopoeial requirements for the preparation. By extension, therefore, generics are assumed to be identical in dose, strength, route of administration, safety, efficacy, and intended use.

Reasons for cheaper price

The principal reason for the reduced price of generic medicines is that these companies incur less costs in creating the generic drug and are therefore able to offer a lower price and still maintain profitability.

Manufacturers of generic drugs are mainly able to avoid the following three costs that brand name pharmaceutical companies incur: (1) costs associated with the research and development of the drug; (2) costs associated obtaining regulatory approval (i.e. proving safety and efficacy of a drug); and (3) marketing costs.

First, Generic manufacturers do not incur the cost of drug discovery and instead reverse-engineer existing brand name drugs to allow them to manufacture bioequivalent versions.

Second, generic manufacturers do not bear the burden of proving the safety and efficacy of the drugs through clinical trials - rather, generic manufacturers must prove the bioequivalance to the existing drug.

Third, these companies receive the large benefit of the marketing that goes into pushing the innovator drug. The drugs that generic manufacturers are selling have been on the market for usually a decade or more and do not need additional advertising. For the same reason, generic manufacturers also do not give away sample doses to promote their products. The significant research and development and marketing costs incurred by the large pharmaceutical companies in bringing a new drug to the market is often cited as the reason for the high cost of new agents - they wish to recover these costs before the patent expires. Generic manufacturers do not incur these costs, with bioequivalence testing and the actual manufacturing process costing relatively little, and are able to charge significantly less than the "innovator" brand

Ensuring bioequivalence

In the USA the Food and Drug Administration (FDA) is responsible for making sure that generic drugs are "safe and effective." The approval process for generic drugs began in the late 1960s. Generic drug manufacturers were required to prove that their formulation exhibits bioequivalence to the innovator product. Over the past several years there have been studies that have shown the effectiveness and safety of some generic drugs. Generic drugs are always less expensive and can save patients and insurance companies thousands of dollars supposedly without compromising the quality of care. The FDA must approve generic drugs just as innovator drugs must be approved. Bioequivalence, however, does not mean that generic drugs are exactly the same as their innovator product counterparts, as chemical differences do exist. Some doctors and patients emphatically believe that certain generic drugs are not as effective as the products they are meant to replace (ie. Prozac, Oxycontin), and consumers would undoubtedly benefit from more clinical studies done on drug by drug basis. Generic drugs start out at first being fairly expensive, however the price of the generic product decreases as the rate of production increases.

As an interesting case study in the use of generic equivalents of name-brand agents, warfarin has been only available under the trade name Coumadin in North America until recently. Warfarin (either under the trade name or the generic equivalent) has a narrow therapeutic window and requires frequent blood tests to make sure patients do not have a subtherapeutic or a toxic level. A study performed in the Canadian province of Ontario showed that replacing Coumadin with generic warfarin was considered safe.[2] In spite of the study, many physicians are not comfortable in allowing their patients to take the branded generic equivalent agents.[3]

 

Re: Drug manufacturing and quality control

Posted by Squiggles on February 26, 2007, at 12:21:30

In reply to Re: Drug manufacturing and quality control, posted by notfred on February 26, 2007, at 11:27:39


Thank you. This issue is really beyond my head.
And as I said, I did not want to pit generic drugs as being truly bioequivalent or not. Many other factors could corrupt a drug at any time, in any dose, from any source.

I *did* take a look at "Sheldon Preskorn" and
"generics" key words/phrases, and got many hits; among them:

http://crazymeds.org/sites.html

This issue is very complex and it looks like all the statisticians and mathematicians who can make heads or tails of drug development, are involved. Ironically, they are involved in a question which has already been answered in the initial development of generics. I guess there are sceptics everywhere.

Squiggles

 

Matrics Workshop on Neurocognitive Drugs (FDA)

Posted by Squiggles on February 26, 2007, at 18:00:31

In reply to Re: Drug manufacturing and quality control, posted by notfred on February 26, 2007, at 11:27:39

Whenever I come across seminars of this type,
I feel as if I am spying.:-) It's pretty "inner-circle stuff", but it certainly gives you an idea of how and what decisions are made by the Government in the development, evaluation and decision-making process of how to treat the mentally ill population.

This is a pdf file:

"UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, NATIONAL INSTITUTES OF HEALTH, NAT'L. INSTITUTE OF MENTAL HEALTH:

In the matter of:

FDA NIMH MATRICS Workshop on Clinical Trial Designs for Neurocognitive Drugs for Schizophrenia.

Neuroscience Center, Conf. Rm. C, 6001 Executive Blvd., Rockville, MD, Fri., April 23, 2004.

---------------------

What I find fascinating about this workshop, is the long-term search for appropriate antipsychotics targeted specifically at cognitive disabilities in schizophrenia. It seems to me that it is already assumed that cognitive disabilities in mental illness are neurologically specific. What I mean by that, it does not seem to be an option in the research, that affective maladies, as in manic-depression, can very well distort cognitive ability. Moreover, the search for drugs to stabilize neurocognitive states is imperative in the FDA. It sounds like the government wants the mentally ill to *appear* OK, with the new drugs, even though they do not feel OK.

Squiggles

 

Re: Drug manufacturing and quality control

Posted by laima on February 26, 2007, at 18:11:36

In reply to Re: Drug manufacturing and quality control, posted by Squiggles on February 26, 2007, at 12:21:30

Well- for me the Barr generic and the Shire brand adderall behave like two entirely different meds: radically different effects, not a matter of potency. So I am not quite "getting" this bioequivalency thing, though I comprehend that's the theory and intention for generics. I'm just not so sure it's always the reality. If the difference in this case was a matter of potency, I could simply take more. Biggest concern: one makes me depressed and feels like speed at times-especially when it suddenly kicks in, then later it ends in a "dump"; the other boosts my mood gently but significantly, and feels like not being on a drug at all-no perceptable anything as it wears off-takes effect so gradually I can't even tell how long after I take it that that is. My doctor is the sole person who is not surprised by any of this, and I'm sorry that I end up feeling defensive about it not just at the numerous pharmacies I visited while hunting for it, but here. It's not my imagination, and I'm not a pharmaceutical industry spokesperson on an anti-generic crusade, nor a mental case perceiving imaginary differences. Sorry there haven't been any answers or clues regarding my big question about who is now specifically calling the shots in the manufacture of the brand version, I guess no one really knows at this point, and really, sorry I mentioned anything at all. Insisting that what I'm experiencing with these meds isn't imaginary only makes me feel worse.

 

Re: Drug manufacturing and quality control » Squiggles

Posted by laima on February 26, 2007, at 18:13:54

In reply to Re: Drug manufacturing and quality control, posted by Squiggles on February 26, 2007, at 12:21:30


Thanks for the link, Squiggles. I really appreciate, and I'll do some research there later.


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