NYreefNoob

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anyone ever wonder why they need commercial for a drug you need a prescription for ? ever wonder how a drug gets fda approval with more side effects then the initial problem as well as possible death from some ?
 

NYreefNoob

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naw i know that, but it's a prescription that a doctor has to prescribe, i know why they do it { oh that ailment fits me let me go to the doctor and tell him i need this } but with all the side effects from alot of these how do they figure it's benificial when the side effects are worse then the main problem
 

regal

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....but with all the side effects from alot of these how do they figure it's benificial when the side effects are worse then the main problem.....

It is all about risks and benefits. Most of the medications (prescribed or OTC) have potential side effects. e.g. overdosing in Tylenol can severely damage your liver which can kill you if you don't get treated in time. If the benefits outweight the risks, ppl can justify taking it, making it or promoting it. Pharmaceuticals are billion dollars industry in our country. They can justify anything.:shhh:
 

Domboski

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I never wonder...I work in the field for a living :) It is much more complicated than I could even write in a thread or anyone else for that matter. There used to be a feeling for catagories such as cancer, DTC (Direct to Consumer) advertising was not necessary because if you have cancer you are going to take the drug the Dr. prescribes right? Well with the positives of the information available now with the WWW there is also the negative. Patients thinking they know better than doctors. Of course a lot of motivation is money but there is also a compliance issue as well. The FDA is a severely under-funded organization and is probably one of the best gvt agencies at using its resources efficiently. Not only do they monitor and approve drugs from a clinical standpoint but they also monitor the advertising and promotion. A lot of money is spent to get a drug to market and during post marketing. Having worked in the industry I feel confident in the decisions the FDA makes. As with anything, they are not going to be perfect.

In short, the commecials are meant to drive you to have a discussion with your doctor. Your doctor will ultimately make the best recommendation they can for you, their patient. There is over 17,000 drugs available in the US alone. Do you think any human being can remember them all and their mechanisms of actions, molecular makeup, attributes and benefits? Of course not, that's why there has been a movement towards DTC promotions (there is a number of ways information is provided to physicians). :)

Don't mistake my post as me believing money is not one of the main motivations behind drug development but that does not make it evil. Find me any product developed that money was not a consideration? The FDA has people's lives in their hand and they take special care to make sure people who need medication are as safe and as informed as possible. As regal mentioned, sometimes the side effects are necessary because the benefits of the drug outweigh the side effects. In some cases it's vice versa and the FDA usually will not approve such drugs.

My question to you is do you ever wonder why drug names are so weird, hard to say or remember? Well that is the FDA protecting you against "fanciful" or "exagerative" names that may cause drug abuse or misconceptions on the ability or the intended use of a regulated drug.

I could go on all day. :biggrin:
 
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jejton

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Basically what Dom said.

You, a 51 yeard old man, watches a commercial showing a 60 year old man dancing on a beach with a 30 year old model. Then a voice asks, " Are you a male over the age of 50? Do you know longer have the same ability to make love as you did when you were 18 ? You might benefit from Pickyourpenisoffthefloorlittlebluepillamijig. Next time you see your doctor, ask him if Pickyourpenisoffthefloorlittlebluepillamijig is right for you. "

Now what 50 year old has the same sexual powers he did when he was 18? So of course every 50+ man watching the commerical is going to ask his doctor about the pill, regardless of whether he needs it or not. Thats a lot of people asking their doctors for a pill. A certain percentage need it, but more will get it. Makers of pill see their profits rise.

Another ( this one was told me by an ENT ) scenario is when a drug is going off patent, or even more so when a prescription drug is going OTC. Branding. A certain nasal spray ( I forgot which one he told me ) was about to go off patent, and the whole class of drugs was turning over-the-counter, so this company made a very successful advertising campaign to instill the brand in consumer's mind which allowed them to corner the market.

I dont think pharm companies are all evil ( though they don't always play the moral card either ) but direct to consumer advertising has definately become problematic, at least for doctors.

As for the side effects, go read the warning on the Tylenol you took last night. Major side effects have to be listed, to avoid litigation, as per FDA rules. However, for fear of litigation, side effects are listed - even if they are very rare - if they would be something very serious.
 

Domboski

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All true except this:


Another ( this one was told me by an ENT ) scenario is when a drug is going off patent, or even more so when a prescription drug is going OTC. Branding. A certain nasal spray ( I forgot which one he told me ) was about to go off patent, and the whole class of drugs was turning over-the-counter, so this company made a very successful advertising campaign to instill the brand in consumer's mind which allowed them to corner the market.

Trust me, physicians of any type are only giving you their opinion of what was done behind the scenes. They do not know for sure. It is impossible to corner the market just through advertising. The drug actually has to work. Advertising can increase awarness, usage and profits but it can not make a mediocre drug a blockbuster. The drug actually has to work and work great. Consumer packaged goods company may be able to use advertising to corner a market but even then its not easy (It is impossible in the pharmaceutical arena). They certainly can carve their piece of the market out but between the FDA, third party payers (insurance companies), physicians and patients no drug will get anywhere unless it works as promoted. Third party payers probably are the most influential when it comes to a drug being prescribed. A Doctor will almost always prescribe a drug that is covered by a third party payer over one that is not except for specialty conditions. As a patient, you can tell your Doctor you want a specific drug but if he tells you it is not covered by insurance and it is going to cost you $500 a month out-of-pocket versus another drug that you only have a small copay plus it works just as good, you'll think again about which one you use.

DTC advertising is an old hat. More and more I'm hearing marketing efforts starting to focus on third party payers.

Again, there is so much more detail involved here and I can go on all night. The best thing you can do as a patient is don't look at the commercials but listen to them. Have a discussion with your Doctor and make the best decision possible.

A quick example that I find very sad is there are people with HIV who have been taking anti-retrovirals as treatment for 20+ years. What they are seeing now is these anti-retroviral takers are starting to suffer from lipidystrophy (displaced fatty deposits) as a result of anti-retroviral treatment. Because this is a side effect of the anti-retrovirals, many patients refuse to take the antiretoviral drugs even though they have HIV. Many early HIV diagnosed patients may not feel ill so they don't take the drugs of fear of lipidystrophy and other anti-retrovial side effects. That is a major compliance issue. There has been a big push through education to get third party payers to cover these drugs that treat lipidystrophy because patients are not getting the treatment they need. As silly as it sounds it is very serious. Third party payers look at lipidystrophy as a cosmetic issue and do not cover the drugs for it. That is a very short-sighted view on HIV and the effects of treatment. And I would even go as far to say it is an unrealistic evaluation of the effects lipidystrophy has on the over health of people with HIV. Many people with HIV do not start their treatrment until they end up in the hospital even though they have been diagnosed early on because of the fear of looking "fat". Again, it seems silly but it is reality.
 
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Killerdrgn

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Another ( this one was told me by an ENT ) scenario is when a drug is going off patent, or even more so when a prescription drug is going OTC. Branding. A certain nasal spray ( I forgot which one he told me ) was about to go off patent, and the whole class of drugs was turning over-the-counter, so this company made a very successful advertising campaign to instill the brand in consumer's mind which allowed them to corner the market.

Both Nasonex and Claritine did/ are doing this.
 

Domboski

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Another thing to keep in mind is that for a drug to go OTC it has to meet safety and efficacy parameters that warrant this. Usually that means the drug is fairly safe and effective over a long period of time. Prilosec, Claritin, Nasonex, Lamasil, Zyrtec and many others meet these qualifications. You can translate that into they work great and they are fairly safe. They are not mediocre drugs that were brainwashed into the mind of would be users :). They are also therapeutic category assessed. Cancer or blood pressure drugs will never be OTC. Allergy, Sinus, Gerd and conditions similar can become OTC.
 
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TimberTDI

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If it weren't for those commercials; I would have never know that your bowels could leak unknowingly.

I think it's just more to make the consumer comfortable with the name of a drug. So that when the doctor tells the patient,"I'm going to put you on Zyrtec." The patient (even though they have no idea what the drug does) recalls those commercials and has a sense of familiarity.
 

jejton

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All true except this:




Trust me, physicians of any type are only giving you their opinion of what was done behind the scenes. They do not know for sure. It is impossible to corner the market just through advertising. The drug actually has to work. Advertising can increase awarness, usage and profits but it can not make a mediocre drug a blockbuster.

Dom - I was referring to drugs that are going OTC. They dont have to work. Between the average American's susceptibility to slick marketing, lack of science education, and the placebo effect, many drugs are sold ( again I'm referring to non-prescription, though even many prescription drugs are found, after large studies, to really have no or minimal effect ) that don't necessarily work or work well. Just look at the herbal drug market. Its a billion plus dollar market, yet almost none - thats right, not one, of those formulations have actually undergone rigorous testing to prove they do whats claimed. One study found that a large percentage dont even contain what they are advertised ( thanks to the large herbal supplements lobby, herbal supplements are categorized as food and not drugs. Therefore they don't need FDA approval ).

As for your argument about insurance companies and cost of drugs, well ask any doctor or insurance company rep how often they have to work with patients who are demanding a drug that is inappopriate for them due to something they saw or heard from marketing or friends, family, etc. Do a quick test. Ask people what drugs come to mind for:
impotence - most people will reflexively ask for Viagra
depression - Valium
headache - tylenol, aspirin
acid reflux - nexium ( the purple pill ), prilosec

Many conditions can be treated by more than one drug (Viagra has competitors now, for instance ) and if they are both covered by insurance, patients will often request the one they are familiar with.

Drug marketing works. Otherwise you would be out of a job. Yes, the majority is aimed at providers but big pharm wouldnt spend what they do on DTC advertising if it wasnt worth the $$$ ( the pharm industry is one of the most profitable in the country. I imagine with the current ecomic crisis, it will only get better as more people will be needing antidepressants, blood pressure meds and ED drugs so if you're looking for an investment ). Dont get me wrong, I dont think its all bad but there are a lot of problems with DTC marketing as it is.
Most important thing is what Dom said - have a good open relationship with your doctor and discuss your concerns ( then go harrass the insurance companies and politicians so that doctors can actually afford to spend the time with patients thats needed ).
 
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Domboski

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I'm not saying marketing doesn't work. What I am saying is humans are not brain-washed Zombies as you make it sound. When it comes to OTC drugs, most of them were prescription drugs at one time and had to meet certain criteria to become OTC. Any FDA regulated drug has to work period. It doesn't have to work better than another but it does have to work and meet certain criteria. There is "cost of entry" safety and efficacy factors a drug has to meet bottom line. If it meets that criteria the drug works as intended. You know better than most if a drug works great for me it may not work so good for you because of the many differences in us as individuals. Therefore there is options. Lipitor is probably the best cholesterol drug ever but it does not work for everyone and that is why you end up with competition that on a clinical level are inferior to Lipitor (inferior doesn't mean they don't work because they do).

All the drugs you mentioned above that patients ask for are superior performance drugs in their class. They have more to promote than others. There is no lies in promotion for FDA regulated drugs. Nexium is much more powerful than Prevacid. Tylenol has a long history of working with little side effects. Valium is no longer a top performer in the depression category and barely asked for by patients. In most cases Valium carries negative stigma and patients don't want it. Viagra created the ED (erictile dysfunction) market and it works great. Therefore it carries the big name it does. Levitra was second in the ED market and promoted itself in the first year with over a billion dollars. Do you know why you don't hear its name that often? It doesn't work as well as Viagra. Levitra still makes money as it is an alternative for those Viagra does not work so well. I bet you have heard of Cialis though? It works differently than the other two ED drugs and works as promised/ promoted.

Herbal supplements are a whole different story. Anyone who takes herbal supplements that are not FDA regulated are crazy. Its not lobbying in the traditional sense. Most of their arguments are based around the consitituion and their rights. They are using third party published data for a specific herb to state the claim of its use. Generic drug companies use the same technique. When a drug goes off patent, a generic company reverse engineers the drug and files for approval. The only clinical data a generic company has to present to the FDA is that their generic drug is statistically bioequivalent to the branded drug. They do not go through the same rigor clinically that a branded drug did (reformulations is the branded drug exception). So basically if I have done billions of dollars of research to show that a certain compound works you are able to copy my compound at the fraction of the clinical development cost I spent when it comes off patent. You wonder why generic companies get sued all of the time :scratch:

Here is a quick hypotheitcal to make my point. Lets say I come out with a new product and I tell everyone that my new product will make you fly. I advertise it during the superbowl. 3 million people go out and buy my product. Guess what, no one could fly. I made a boat load of money right? I have the last laugh right? Wrong. No one buys my product again or anything else I offer and I get my ass sued and lose all of the money I made and then some.

I've never in 10 years of working in this business had any company (healthcare or Consumer goods) ask me to create a name or brand positioning that the product could not deliver on. What these companies try to do is maximize the return on what their product does best.

Herbal suplements in theory are able to perform what they claim based on third party research. They do have to claim their products have not been evaluated by the FDA which should be a deterent to anyone thinking of using them. I'm sure in the future at some point they will have to be reviewed by the FDA.
 
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jejton

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Dom - I'm not arguing with most of what you say, but the fact remains. Pharmaceutical companies spend a lot of money on advertising both to doctors and to patients, and they do it for a reason. Is there a benefit, for the average person, from that marketing? Yes. Are there downsides. Yes. Advertisements, for any product, rarely make outright false claims - for the reasons you stated - but they can make exagerations, innuendos, false comparisons, etc. Like you said, its a complicated issue that doesnt lend itself to online discussions. Next time you're in the area, I'll pull out some beers and we can discuss this while figuring out how to get rid of the briopsys in my tank. Its a very interesting and contentious subject ( we spent quite some time on this, and associated topics such as pharm funded research, in school )

Regarding herbal supplements, it was industry lobbying, not constitutional rights activists, that got the law passed.

Here's an interesting article with an excerpt below
http://www.quackwatch.org/01QuackeryRelatedTopics/herbs.html
"The Dietary Supplement Health and Education Act of 1994 included herbal products in its definition of "dietary supplements," even though herbs have little or no nutritional value. (The bill was spearheaded by the health-food industry in order to weaken FDA regulation of its products.) Herbal or other botanical ingredients include processed or unprocessed plant parts (bark, leaves, flowers, fruits, and stems) as well as extracts and essential oils. They are available as teas, powders, tablets, capsules, and elixirs, and may be marketed as single substances or combined with other herbs, vitamins, minerals, amino acids, or non-nutrient ingredients. Products containing multiple herbal ingredients may produce adverse effects that are impossible to predict. A 1999 survey by Prevention magazine's found that 12% of herbal remedy users reported adverse reactions [6]."
 

Domboski

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I don't know herbal supplements that well except I will almost never take them becuase they are not evaluated by the FDA. I'm sure there is some loop hole they are using.

I know you are not arguing with me Eric. I just don't want people not taking drugs that will help them because they think the advertising is false. Compliance has become a major issue and the skeptical outlook on drugs is a major part.

Keeping with Cialis, if you remember the initial ads, they had the couple in the same tub. The FDA made them split them apart. Seems silly doesn't it? That is how detailed the FDA is in its review and how much they consider the perception an ad will create.

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Beers sound good to me :) We might drink too many discussing this topic though
 
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jejton

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My main issue with the advertising is when it causes patients to not take the correct drug because they want the one with the cool advertising, or when they want a medication for something that can be treated without medication. A bigger problem than the marketing is when pharm companies sponsor ( especially when its not done openly ) drug trials and research. Thats when you really get problems. If you're interested, I can send you some of the papers we discussed that looked into that.

Speaking of pharm, I have to get off this damn website and go finish studying for my pharm exam.
 

Domboski

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I know the fine line and I am not defending advertising per se. A pharmaceutical company is no different when it comes to promotional goals than Nike except there is the FDA to keep a watchful eye on the pharma company :)

There is definitely as much negative to advertising as there is positive. I have interviewed thousands and thousands of physicians of all types over the past 10 years. I know very well how they think as well as patients. I don't create advertising. I help companies position their products to maximize usage. There has to be clinical data to back any claims they make or it is illegal. Not so much so for Nike :)

Medical education for drugs in clinical trials is another discussion of its own. I agree that it is shady but the funding has to come from somewhere. These trials are expensive and take a long time. I have faith that KOLs (key opinion leaders a.k.a. highly respected physicians) that usually present clinical drug information keep an unbiased perspective on the product in trials. If a KOL stands up at a conference and talks negatively about a product in trials that product is as good as dead. Millions and millions of dollars are lost on products that are abandoned for poor performance in trials or for not getting approved by the FDA.

Think about spending a $1 miilion dollars on a fish and then it dies the first day you have it with no money back gurantee. Multiply that by at least 100X and that's what happens very often in healthcare.
 

Domboski

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If it weren't for those commercials; I would have never know that your bowels could leak unknowingly.

LMAO!

I think it's just more to make the consumer comfortable with the name of a drug. So that when the doctor tells the patient,"I'm going to put you on Zyrtec." The patient (even though they have no idea what the drug does) recalls those commercials and has a sense of familiarity.

This is exactly right. They also want the patient to ask for a drug too. Physicians are humans. If they get comfortable with one brand their instinct is to keep using it until someone gives them a good reason to switch. The Pharma companies at the very least want that conversation to take place between the patient and a physician so the best treatment option is moved forward with.
 

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