Matthew_Herper posted:

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During the Super Bowl, a representative of the pharmaceutical company Eli Lilly posted the on the company’s corporate blog that the average cost of bringing a new drug to market is $1.3 billion, a price that would buy 371 Super Bowl ads, 16 million official NFL footballs, two pro football stadiums, pay of almost all NFL football players, and every seat in every NFL stadium for six weeks in a row. This is, of course, ludicrous.

The average drug developed by a major pharmaceutical company costs at least $4 billion, and it can be as much as $11 billion.

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Yukishiro1 posted:

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New drugs are going to continue to cost more and more and provide less and less benefit for the forseeable future, at least until there is some fundamental breakthrough in drug design.

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Taliesihne posted:

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Sounds like a pretty inefficient business.

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GrilledCheez posted:

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The pharmaceutical industry as it stands right now is ludicrous. When we have our best and brightest and most expensive researching hair growers at an eight to one rate over cancer killers, you know we've failed ourselves and our children.

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Cawlin posted:

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Yukishiro1 posted:

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New drugs are going to continue to cost more and more and provide less and less benefit for the forseeable future, at least until there is some fundamental breakthrough in drug design.

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It's not about how we design drugs, it's basically about our understanding of physiology.

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Kjarhall posted:

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How much of that money is spent trying to get FDA approval?

Because i've always wondered how some of these drugs, with their menu of side effects get passed at all, and why they don't shelve them before spending so much and work on items that are more positive effective.

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Bowlartz posted:

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I would assume all of the research that goes no where or drugs that ultimately fails to get approval and die add a considerable amount to that total.

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GrilledCheez posted:

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The pharmaceutical industry as it stands right now is ludicrous. When we have our best and brightest and most expensive researching hair growers at an eight to one rate over cancer killers, you know we've failed ourselves and our children.

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Cawlin posted:

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Kjarhall posted:

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How much of that money is spent trying to get FDA approval?

Because i've always wondered how some of these drugs, with their menu of side effects get passed at all, and why they don't shelve them before spending so much and work on items that are more positive effective.

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That's kind of a complex question.

Basically just about EVERYTHING that goes into developing a drug (outside of the initial drug discovery phase) is for FDA approval.

Here's how it works in a very general sort of nutshell:

1) Drug discovery phase - these are the chemists, biochemists, and jungle-galavanting folks working on synthesizing new compounds, isolating them from exotic flora and fauna, etc. They discover a new compound that is suspected to have some activity in some physiological system or on some mechanism of disease. This is the "freelance" work - the work that's not done to comply with FDA - the biggest regulatory issue here is complying with patent and/or intellectual property laws. This is generally "cheap" in terms of overall costs and often, it's much cheaper to buy the rights to a compound than to make or isolate one on your own...

2) Initial SAFETY trials - this is studies in animals where they determine if taking this compound is going to have any sort of very obvious safety issues. Studies of the metabolites of the drug are conducted as well to determine a number of preliminary safety issues. These studies are done for the FDA - and as long as you can show a reasonable safety profile on the drug (and a bunch of other things about your plan going forward) the FDA may (or may not) grant approval to go forward with trials in humans - clinical trials.

3) Cinical trials - various phases - with groups of subjects varying from as few as 10 or 20 individuals to thousands. Time duration can be weeks, months, or years. The safety of the drug is continually monitored during clinical trials AND the efficacy of the drug is monitored and characterized. It is during clinical trials when all of the salient details about the drug's safety for age groups (children vs. adults) as well as the dosage and efficacy data are established. All phases of clinical trials are done with heavy regulatory oversight from FDA.

4) Manufacturing - you have to show that you can manufacture the drug now and there are a large number of FDA driven controls which go into the manufacturing process as well... sometimes you can simply add a new compound into an existing manufacturing facility, sometimes you have to have a few pieces of specialized equipment or a new manufacturing suite within an existing manufacturing site's campus, and sometimes you need or opt to use a totally different and new to your company manufacturing site... but FDA regulation is heavy in the manufacturing realm as well.


So in short, almost ALL of the activities for bringing a new drug to market are undertaken because of the FDA.

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Kjarhall posted:

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Do any possibly use "point of no return" where they've spent so much, they become reckless trying to get it to market, because failure is no longer an option?

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Kjarhall posted:

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What i'm really getting at is - how much less would they spend if they abandoned the ones that they're having difficulty getting approval on or there are significant safety questions (extra money spent to get FDA approval or potential lawsuits after the drug is on market) ?

Do any possibly use "point of no return" where they've spent so much, they become reckless trying to get it to market, because failure is no longer an option?

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Yukishiro1 posted:

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And most of them do jack shit when they don't actively hurt you.

We've already invented pretty much all the low-cost high-benefit drugs out there to be invented. New drugs are going to continue to cost more and more and provide less and less benefit for the forseeable future, at least until there is some fundamental breakthrough in drug design.

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Cawlin posted:

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GrilledCheez posted:

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The pharmaceutical industry as it stands right now is ludicrous. When we have our best and brightest and most expensive researching hair growers at an eight to one rate over cancer killers, you know we've failed ourselves and our children.

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Source?

Our nation's best and brightest are in finance, figuring out ways to buy governments and funnel the wealth and control of the planet into fewer and fewer hands.

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vn_nnanji posted:

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Cawlin posted:

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GrilledCheez posted:

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The pharmaceutical industry as it stands right now is ludicrous. When we have our best and brightest and most expensive researching hair growers at an eight to one rate over cancer killers, you know we've failed ourselves and our children.

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Source?

Our nation's best and brightest are in finance, figuring out ways to buy governments and funnel the wealth and control of the planet into fewer and fewer hands.

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Tell that to the several hundreds of biotech firms in San Diego, SFO, Boston and RCP.

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vn_nnanji posted:

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Yukishiro1 posted:

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And most of them do jack shit when they don't actively hurt you.

We've already invented pretty much all the low-cost high-benefit drugs out there to be invented. New drugs are going to continue to cost more and more and provide less and less benefit for the forseeable future, at least until there is some fundamental breakthrough in drug design.

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They are working on addressing diseases at the level of DNA, creating compounds that will address just the disease and not medicate the whole body when only part is needed. They literally are rewriting the transcription of the disease at the rDNA level, interrupting the diseases ability to replicate and prosper.

The main roadblock is drug delivery but Oligonucleotide drugs are already in use. Naturally the costs are staggering, for many reasons, some natural and some artificial.

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vn_nnanji posted:

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They are working on addressing diseases at the level of DNA, creating compounds that will address just the disease and not medicate the whole body when only part is needed. They literally are rewriting the transcription of the disease at the rDNA level, interrupting the diseases ability to replicate and prosper.

The main roadblock is drug delivery but Oligonucleotide drugs are already in use. Naturally the costs are staggering, for many reasons, some natural and some artificial.

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Cawlin posted:

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Generally, one of the reasons you'd see a drug fail in late stage clinical trials is due to adverse events which are safety issues - i.e. the drug causes liver failure or something like that, or a person taking the drug committed suicide and it was determined to be due to a hormonal imbalance brought about by your drug. You'd have to get a whole lot of people to be willing to lie for you to get those sorts of things past the FDA - basically you'd have to not report them or you'd have to get a number of physicians to falsify reports - the very height of fraud would have to be committed. That is not to say that I don't believe it happens, but it's a pretty big deal...

Another reason for a drug to fail in late state clinical trials would be lack of efficacy. There's only so much data massaging you can do to show efficacy. The FDA has great statisticians working for them too and when a drug company tries to present data of a questionable nature, the FDA is all over them about getting to the bottom of it if they smell a rat.

In short, yes, companies may try to be reckless with bringing a drug to market but there are a fair number of safeguards against that, not the least of which is the FDA. Incidentally, the folks at FDA are a pretty serious bunch...

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Yukishiro1 posted:

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I'm sure that's what their PR firm says in their brochures. When's the last time anyone invented a really truly effective drug that fundmentally changed our approach some area of medicine? Something you could put in the same catagory with penicillin or a polio vaccine or the birth control pill.

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Yukishiro1 posted:

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These days the drugs that get released are mostly crap that maybe lowers your chance of something or other by a few % points, has nasty side effects that may be about the same as the benefits, and costs thousands of dollars per year to do it.

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Eager_Igraine posted:

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It seems like this kind of issue is being addressed largely in the marketing. The number of drug advertisements I see on television has increased dramatically over the past few years, and the listed risks in their use also seems to have increased. "May cause death" and "may cause suicidal thoughts" have become common and also weasel words like "... has been suggested to help [symptom or illness]..."

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Cawlin posted:

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Yukishiro1 posted:

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I'm sure that's what their PR firm says in their brochures. When's the last time anyone invented a really truly effective drug that fundmentally changed our approach some area of medicine? Something you could put in the same catagory with penicillin or a polio vaccine or the birth control pill.

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Look up seratonin uptake inhibitors.

Look up statins.

Consider what's going on with stem cell research now (which has been artificially on hold for 20 years).

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Yukishiro1 posted:

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Cawlin posted:

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Yukishiro1 posted:

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I'm sure that's what their PR firm says in their brochures. When's the last time anyone invented a really truly effective drug that fundmentally changed our approach some area of medicine? Something you could put in the same catagory with penicillin or a polio vaccine or the birth control pill.

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Look up seratonin uptake inhibitors.

Look up statins.

Consider what's going on with stem cell research now (which has been artificially on hold for 20 years).

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None of those have anywhere near the effect of any of the things I listed. The anti-depressant drugs might come closest, but they also create the biggest number of problems and are rampantly overprescribed.

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Yukishiro1 posted:

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Pharma profits come mostly from % drugs with serious side effects which are relentlessly pushed on people through TV advertising and truly corrupt bribes to doctors.

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Yukishiro1 posted:

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And no, obviously % drugs arn't necessarily worthless, and yes, having a x% less chance of heart attacks is better than not. But the amount of money spent to generate those effects is nowhere near as efficient as the older drugs. Penicillin saved millions of lives for what was basically pennies by the time it went into full production. These days we spend 10,000 dollars a year on lowering someone's risk of a heart attack by 3% while potentially giving them all sorts of nasty side effects, when if they had just eaten and exercised right in the first place they would have reduced their risk by many times that amount.

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Yukishiro1 posted:

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What part? That revenues come from % drugs? That's just facts.

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Yukishiro1 posted:

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Or the bit about relentlessly pushing drugs on patients and doctors? Don't you work in pharma? You honestly don't know how this works? How pharma targets doctors and takes them out to expensive dinners with attractive young sales agents and does all sorts of things to try to get doctors to push their drugs?

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Cawlin posted:

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Eager_Igraine posted:

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It seems like this kind of issue is being addressed largely in the marketing. The number of drug advertisements I see on television has increased dramatically over the past few years, and the listed risks in their use also seems to have increased. "May cause death" and "may cause suicidal thoughts" have become common and also weasel words like "... has been suggested to help [symptom or illness]..."

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Marketing is a whole other ball of wax. Marketing is subject to FDA regulation too by the way...

Bear in mind these few things:

1) If someone during a clinical trial suffers an adverse event, and medical science cannot conclusively tie it to your drug, but also cannot conclusively say your drug had nothing to do with it, you are required to report it and to include it on your labeling AND in your advertising.

2) You are forbidden from advertising what your drug supposedly does in "concrete" terms. You may not say "This drug unequivocally reduces your risk of heart disease". You have to say "Ask your doctor if XYZ drug might be a good candidate for you!"

There are more forces at work there than are apparent with respect to labeling, marketing claims and so forth. In the end, the FDA wants your physician to make the decisions about your therapies, not the drug companies.

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Eager_Igraine posted:

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Cawlin posted:

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Eager_Igraine posted:

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It seems like this kind of issue is being addressed largely in the marketing. The number of drug advertisements I see on television has increased dramatically over the past few years, and the listed risks in their use also seems to have increased. "May cause death" and "may cause suicidal thoughts" have become common and also weasel words like "... has been suggested to help [symptom or illness]..."

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Marketing is a whole other ball of wax. Marketing is subject to FDA regulation too by the way...

Bear in mind these few things:

1) If someone during a clinical trial suffers an adverse event, and medical science cannot conclusively tie it to your drug, but also cannot conclusively say your drug had nothing to do with it, you are required to report it and to include it on your labeling AND in your advertising.

2) You are forbidden from advertising what your drug supposedly does in "concrete" terms. You may not say "This drug unequivocally reduces your risk of heart disease". You have to say "Ask your doctor if XYZ drug might be a good candidate for you!"

There are more forces at work there than are apparent with respect to labeling, marketing claims and so forth. In the end, the FDA wants your physician to make the decisions about your therapies, not the drug companies.

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I am noticing more frequently though that the language chosen for advertising several drug products specifically allow room for them to have absolutely no positive effects at all, and maybe kill you. That suggests to me that drug companies are finding routes to the market for products that kinda suck. There appears to be a difference between saying that your product, in clinical trials and used as recommended by a physician, has been shown to have [x] impact for most people in the trials, and saying that your product, in clinical trials and used as recommended by a physician, might have had some undefined but presumably beneficial impact although it wasn't quantifiable enough by itself to be measurable during the trials, and it might also kill you.

Just sayin'.

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Cawlin posted:

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Fk yeah!

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Yukishiro1 posted:

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So Pharma is stupid for spending the billions they do on marketing to doctors because no doctor would be influenced by the marketing?

Great argument there, chief.

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Yukishiro1 posted:

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I don't understand anything about science, physiology, or the pharmaceutical OR medical industries but just got out of law school, so that's good enough!

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Yukishiro1 posted:

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Which is why the hire the perky 22 year old sales rep and dress her in a skirt. And take the doctor out to dinner at a fancy resturaunt. And fly him down for a "conference" in Miami. Probably with the aforementioned sales rep. Because all that helps the doctor interpret the data better.

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Yukishiro1 posted:

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I probably know more doctors than you do.

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Yukishiro1 posted:

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You are kidding yourself if you think pharma marketing to doctors is benign and designed only with the best interests of doctors and patients in mind.

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Yukishiro1 posted:

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You keep mentioning law school which is funny because none of the crap pharma pulls with doctors would ever remotely fly in the legal context.

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gatzby posted:

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Which is why whenever he tries to prescribe me something and gives me a brochure or coupon, I immediately ask if there is a generic drug that can do the same thing.

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Yukishiro1 posted:

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Uh huh. They pick the young hot woman because she's cheaper to hire than the young not-hot woman. And all the marketing is just to get them to prescripe your version of the drug and not someone else's. Because no doctor would be influenced in any other way. And influencing them to prescribe your drug, when they would otherwise choose a cheaper one, is totally fine and totally different than influencing them to precsribe a drug that they wouldn't otherwise prescribe, which no doctor would ever do.

I guess you have to do what you have to do to live. Working for pharma that may require you to be willfully blind about what your company actualyl does to ship units.

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Cawlin posted:

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There is no overprescription of drugs in America! And Pharma has nothing to do with it (even though it doesn't exist)!

Also, the gubmint is an expert on everything and would never allow any monkey business! I have never said otherwise! Ever!

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Yukishiro1 posted:

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Yukishiro1 posted:

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I'm not crying. I'm ecstatic. Now I know I never have to worry about a doctor ever prescribing me something I didn't need. And I never need to worry that any of the pharma products advertised on TV might not really be as awesome as they sound. Everyone is just working in my best interests at every turn. And it's just a coincidence that sales rep is hot and wearing revealing clothing.

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Kjarhall posted:

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Thanks for replies.

Eager kinda was on the same track as i was, it just seems that lately there are more drugs advertised that make say "Geez, the adverse effects sound worse than the positive ones. I'd rather suffer with <insert ailment here>.

Plus alot of them seem kinda laughable on the surface - eyelash growing, restless leg syndrome, 'get your period only 3 times a year instead of 4! but there's also a chance it will kill you" kinda stuff, but most of those are for the non-ailment type off stuff.

Then you see the lawyers hawking lawsuits for dozens of drugs. Added all together, it kinda makes Pharma look a little bad.

Kinda made me wonder, so i thought i'd ask for more info, which you provided.

Question though - is it true that they have to put a disclaimer if they had one incident, no matter how many subjects took it? Meaning, it could be one in a million odds, but they still have to say "Could result in death, dismemberment or turning into a zombie"? Seems it would be fairer to allow them to state the 'odds', because otherwise people could assume much worse.

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FDA posted:

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Exhaustive lists of every reported adverse event, including those that are infrequent and minor, commonly observed in the absence of drug therapy or not plausibly related to drug therapy should be avoided.

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Abaddon_Ambrosius posted:

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JFC Cawlin did you just do a hit of meth?

DAYUM that's a lot of letters n words n stuff.

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Kjarhall posted:

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Well i read the whole thing, it isn't often i'm genuinely interested in something written on the Outpost, so congrats on that!

Leave it to Fist though to follow it up with complete, unrelated nonsense.


Last question: So how does the consumer tell the wheat from the chaff in all those warnings? I'm assuming our doctors aren't going to be able to answer off the top of their heads, but do they have access to detail?

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Kjarhall posted:

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Yep thanks.

In other words, there isn't a solution yet that would satisfy me.

And tell them to put the contraindications on ads and booklets in larger than 3 pt. type, so people can read it!

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Cawlin posted:

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...

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Yukishiro1 posted:

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vn_nnanji posted:

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They are working on addressing diseases at the level of DNA, creating compounds that will address just the disease and not medicate the whole body when only part is needed. They literally are rewriting the transcription of the disease at the rDNA level, interrupting the diseases ability to replicate and prosper.

The main roadblock is drug delivery but Oligonucleotide drugs are already in use. Naturally the costs are staggering, for many reasons, some natural and some artificial.

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I'm sure that's what their PR firm says in their brochures.

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Eager_Igraine posted:

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Cawlin posted:

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...

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Wouldn't you agree that Pharma's principal concern as a business is generating maximum profits? of course, as it is for any business
Wouldn't you agree that Pharma has been found guilty in the past of suppressing unfavorable studies?
For fraudulent marketing practices?
For promoting unapproved uses for drugs?
For providing kickbacks to physicians who proscribe selected drugs?
It's not for me to agree or disagree with, these are facts. Also it's a fact that this is not the case with EVERY product marketed by every pharmaceutical company or every drug, or every physician. This sort of behavior has been committed ad nauseum by insurance companies, investment companies, banks, automobile companies, etc. Pretty much every business sector has malfeasance in it - including the government itself lol. That does not mean that the business sector itself is evil or without merit. If you believe that past malfeasance is a guaranteed indicator of present and ongoing malfeasance, well I'd ask you why you aren't railing against every other business sector and your own government as well beacause all of those have this sort of thing in their past. I also know that companies have gone down hard for doing these sorts of things and that regulations have evolved and are evolving to keep it from happening.

Wouldn't you agree that companies (like Pfzier) have been protected from prosecution by the Fed because they were also considered too big to fail? I have no knowledge of that. Do you have a source?
Wouldn't you agree that Pharma has been found using unapproved and experimental drugs outside the US (and the reach of the FDA)? I'm sure it's happened. I don't know why you have an issue with it. If pharmaceutical companies are going to compete in a global market where the USFDA does not have oversight, against companies that also don't have to comply with FDA, why should the businesses handcuff themselves? I don't really know what you're getting at here. If a US pharma company wants to sell drugs in Croatia or who the hell knows where else, if that country allows drugs to be sold without FDA approval (and most countries outside the US do not require FDA approval since you know, the FDA is a UNITED STATES government agency), why should a US pharmaceutical company not attempt to compete in that market? Further, companies from abroad that want to sell in the US must comply with FDA and get FDA approval to do so...

It's also true that pharmaceutical companies give their drugs away to 3rd world nations or sell them for pennies on the dollar because those nations will not adhere to copyright and patent law and will simply buy the drug made "illegally" by another company if they don't give the drugs away or sell at a pittance.

Isn't it amazing that almost half of the contributing authors of the DSM series that has begun medicalizing human behaviors have prior financial relationships with Pharma? No, it's not amazing at all. I'm sure there's some shadiness there. There is also some good coming from it. I'm not a physician, are you? Are you so certain that all of this stuff is inappropriate? Physicians are prescribing this stuff... maybe there's some validity to it? Maybe there isn't as much validity as there ought to be. I don't know though. Supposedly this whole field is virtually brand new...

I don't think Pharma is evil, it is simply amoral, like most mega-corp businesses. But you're kidding yourself if you think Pharma spends more time playing by the rules in spirit as well as letter than it does lobbying to change those rules to its favor, and bending or quietly breaking those rules when there is enough profit for the risk. So pharma is like every other business (which is true), but you have a bone to pick with pharma and not every other business? I am puzzled by your selectivity here. You do realize that the virtually equally enormous lobby from the insurance industry is pretty much the sworn enemy of pharma and that it works just as hard to vilify pharma and against pharma in their lobbying efforts and against pharma in their media and advertising efforts, don't you?

You are also kidding yourself if you think the big bad FDA has either the funding or the manpower to oversee things effectively. Surely you're aware that the FDA itself is overseen and regulated and in recent reviews has been found to be underfunded and unable to perform a satisfactory job in regulating drugs, especially new drugs.

It's an arguable point whether or not FDA is effective or underfunded. Who is overseeing the insurance companies? Who is overseeing the oil companies? Who is overseeing the automobile companies, the banks, the investment companies? We're not in a GLOBAL recession right now because of pharma. It's because of banks and the financiers, and yet your ire is all focused on pharma...

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vn_nnanji posted:

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Other than that I see no reason to spend 3 pages on whether the process is overburdened. Of course it is. If you've got a better system though lets hear it.

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Sin_of_Onin posted:

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Actually big pharm has stolen billions from people and the states which has dragged down recovery for a long time.

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Sin_of_Onin posted:

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Growth in health care costs are clearly one of the top 3 things that are impacting out economy right now and pharm is part of that.

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Yukishiro1 posted:

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Big pharma gets the vast majority of its profits these days from drugs that let people be fat and not die and drugs that let people ignore their problems by medicating away their stress.

This is a fact.

edit: Not that the drugs in question don't have benefits for some people. They do. But they should be niche products, not the everyday products they are. You can't blame pharma for people being fat losers but we spend way too much money on letting people be fat losers. Pharma is just responsing to societal demand to be able to be fat losers but where the money is going does show our priorities.

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posted:

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But when it came to prosecuting Pfizer for its fraudulent marketing, the pharmaceutical giant had a trump card: Just as the giant banks on Wall Street were deemed too big to fail, Pfizer was considered too big to nail.

Why? Because any company convicted of a major health care fraud is automatically excluded from Medicare and Medicaid. Convicting Pfizer on Bextra would prevent the company from billing federal health programs for any of its products. It would be a corporate death sentence.

Prosecutors said that excluding Pfizer would most likely lead to Pfizer's collapse, with collateral consequences: disrupting the flow of Pfizer products to Medicare and Medicaid recipients, causing the loss of jobs including those of Pfizer employees who were not involved in the fraud, and causing significant losses for Pfizer shareholders.

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posted:

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Public records show that the subsidiary was incorporated in Delaware on March 27, 2007, the same day Pfizer lawyers and federal prosecutors agreed that the company would plead guilty in a kickback case against a company Pfizer had acquired a few years earlier.

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posted:

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The report concludes that Pfizer never obtained authorization from the Nigerian government to give the unproven drug to nearly 100 children and infants. Pfizer selected the patients at a field hospital in the city of Kano, where the children had been taken to be treated for an often deadly strain of meningitis. At the time, Doctors Without Borders was dispensing approved antibiotics at the hospital.

Pfizer's experiment was "an illegal trial of an unregistered drug," the Nigerian panel concluded, and a "clear case of exploitation of the ignorant."

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