Despite Spending $50 Billion Per Year In R&D, Pharma's New Drugs Less Effective Than Drugs Developed 40 Years Ago

from the the-future-is-yesterday! dept

More bad news has arrived for consumers. The drugs don't work. Or, they don't work as well as they used to. Despite the exorbitant prices charged for new medications and despite the industry's claims that expensive R&D efforts are driving these prices up, the fact remains that newer drugs cost more and do less, riding a decades-long slide from peak potency.

Research published on Monday showed that the effectiveness of new drugs, as measured by comparing the response of patients on those treatments to those taking a placebo, has plummeted since the 1970s...

The new study in the journal Health Affairs examined 315 clinical trials that compared a drug to a placebo and were published in four of the world's top medical journals (BMJ, Journal of the American Medical Association, Lancet and New England Journal of Medicine) from 1966 to 2010. The drugs targeted the full range of human ills, from cardiovascular disease and infections to cancer, mental disorders and respiratory illness.
In the early years, drugs easily beat the placebo: They were, on average, 4.5 times as effective, where effectiveness means how well they lowered blood pressure, vanquished tumors, lifted depression or did whatever else they were intended to.

But the trend line was inexorably downhill, found Dr Mark Olfson of Columbia University and statistician Steven Marcus of the University of Pennsylvania. By the 1980s drugs were less than four times better; by the 1990s, twice as good, and by the 2000s just 36 percent better than a placebo. Since older drugs were much superior to placebo and newer ones only slightly so, that means older drugs were generally more effective than newer ones.
If this disappointing (albeit somewhat unsurprising) news wasn't damaging enough for an industry many people have developed a healthy distrust for, the passing of the national healthcare plan will make it even worse.
The law established an independent research institute to compare the effectiveness of different treatments for the same condition. That way, patients as well as private insurers and government programs such as Medicare can stop paying for less effective therapies. If the new analysis is correct, then "comparative effectiveness research" could conclude that older drugs, which are more likely to be generics, are better than pricey new brand names that deliver the most profits for drugmakers.
Well, this part is good news for consumers, or at least beneficiaries of the new health plan. If the most effective drug is also the cheapest, everyone wins... almost. Pharmaceutical companies won't be happy, but this really is their own fault. They often tout the (often inflated) high dollar cost of R&D but fail to mention this outlay is routinely outweighed by marketing and administration costs.

There are a few reasons effectiveness may have declined over the past forty years, not all of which are tied to self-interest and profit chasing. One possible factor is that the low-hanging fruit of the pharmaceutical world was plucked first, generating effective medications for simpler ailments. It also could be that those volunteering for clinical trials are increasingly people not having success with currently available drugs. Another factor mentioned in the article is the fact that the quality of clinical trials has increased over the years and the additional scrutiny to detail has narrowed the definition of success.

Despite these factors, many scientists feel there is an underlying truth to the overall claim that older drugs just work better.
While experts agree that tougher trials and similar factors explain some of the decline in drugs' reported effectiveness, "something real is going on here," said Olfson. "Physicians keep saying that many of the new things just aren't working as well," and therefore prescribe antidepressant drugs called tricyclics (developed in the 1950s) instead of SSRIs (from the 1980s), or diuretics (invented in the 1920s) for high blood pressure instead of newer anti-hypertensives.
Then there's this:
"The way the drug regulatory system is set up, even if you have just a small advance, if you market it right it can be very profitable," said [Dr. Aaron] Kesselheim.
The profits-over-effectiveness factor cannot be denied. Marketing budgets routinely meet or exceed R&D budgets because they have to. Pharmaceutical companies are not nearly as interested in breakthrough medication as they are in pushing minor variations or incremental advances. [See also: this "Brain Candy" clip.] Without a ton of marketing, these interchangeable drugs will never find purchasers.
From 2000-2007, 667 new drugs were approved by the FDA. Of those, only 75 (11%) were new molecules that were much better than what we already had. In fact, over 80% of all drugs approved were no better than what we already had. Those are "me-too" drugs. Why do the pharmaceutical companies spend so much on marketing? Because you have to really promote drugs that really have no benefit over others that already exist. You have to convince people to buy those.

You know what needs no promotion? Awesome new drugs that save lives. When was the last time you saw a commercial for chemotherapy? For epinephrine? For steroids? Those drugs need no promotion - doctors just know to use them. But I bet all of you know about Nexium. Or Cialis.
Taking this route has worked for years, at least in terms of profitability. There's no reason to change it now. The results of this research paint a rather unflattering picture of the pharmaceutical industry, but as usual, its representatives seem blithely unconcerned.
The drug industry says it isn't worried. "Our sector is not concerned about objective, high-quality patient-centered comparative effectiveness research," said PhRMA's Burkholder. "We believe the substantial value of our products will continue to be demonstrated."
Frankly, I'm inclined to believe that first sentence. The sector doesn't seem to care what research says about its new, expensive, ineffective drugs. It already has plenty of compliant doctors, paying customers and an exploitable patent system in its corner. That makes the second sentence extraneous. If the market's tied up, the industry doesn't really need to worry about demonstrating value. All it needs to do is maintain course.



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  1.  
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    Anonymous Coward, Jun 6th, 2013 @ 8:16pm

    Eh, the beginning bit can be misleading.

    The intent of much research is to make the drug less effective, but more precise. My pain pills are a good example: the most recent version has a better release cycle in the body, so I get to function physically AND mentally at the same time. The generic is almost the same molecule and does, in fact, help the pain better, but the side effects are much much stronger. I'm totally zonked on those. Lesser effect, but better focused: less side effects, almost the same desired effect, repeat until you need to make it stronger again and upping the dosage doesn't do.

    The intent of much more research is also to get a new patent on anything you can and money gouge, but I thought I'd mention that counter-point.

     

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    RD, Jun 6th, 2013 @ 8:20pm

    Stating the Obvious

    Lets get the Obvious out of the way first, then *all* that follows will make sense:

    There is no money in cures. There is lots of money in treatments. There is OBSCENE money in treatments that are barely effective.

    Now that we understand the ground-rules, we can proceed. Sorry that it obviates most of your article, but there it is.

     

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    Anonymous Coward, Jun 6th, 2013 @ 8:25pm

    nature vs man-made

    nature has had tens of thousands of years to evolve pharmaceuticals. Man just can't compete when trying to make something from scratch instead of imitating.
    willow bark - aspirin
    fungi - penicillin

     

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    Anonymous Coward, Jun 6th, 2013 @ 8:28pm

    Re: Stating the Obvious

    Is that necessarily true . . .?

    Suppose you cure, say, a condition where an opponents treatment has cornered the market. Now, on a long enough timeframe, you're going to come down with something no matter how healthy you are.

    So,
    1. opponent gets less money
    2. You're getting some money for a cure
    3. More people live due to your cure, and more illnesses will occur later down the road, some of which may require treatments you control.
    4. Less medical issues on areas you don't control reduces intersectional population of conditions which leads to more money available for your products & extended lifespan of patients already getting your treatments.

    Seems like open research would solve this problem. (Since you kinda usually need the research that went into the treatments to make a cure)

     

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    Anonymous Coward, Jun 6th, 2013 @ 8:32pm

    Holy s***. Are studies actually suggesting that generics are in many instances viable, and perhaps even better alternatives, to all those drugs causing people to die because they are patented? Obviously the answer is yes in some cases and no in others, but it is fair to note that the mere fact a drug has been patented does not mean meaningful care cannot be provided by the use of other drugs not under patent. This is in part one of the criticisms associated with the repetitive use here of the word "monopoly". Perhaps a "monopoly" as defined here, but infrequently so in actual practice within the medical field.

     

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    ECA (profile), Jun 6th, 2013 @ 9:21pm

    Hmmm..

    $50,000,000,000
    Wages? $40,000 each sounds like a nice wage dont it..
    1,250,000 jobs..
    I DONT THINK SO..

     

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  7.  
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    Coyne Tibbets, Jun 6th, 2013 @ 9:52pm

    Pharma's only motive is profit these days.

    Drug effectiveness is irrelevant: If they can show that they gave it to 1,000 people and 32 people got better (instead of the 31 who got better on [that cheaper drug]) well that's good enough, don't you think? Approve that thing.

    Drug safety is also irrelevant: "Liver damage? Well, yeah, there were 164 of the 1,000 who had liver damage, but we removed them from the study as being 'non-typical'. If we'd reported them in the main results, the FDA might not have let us sell the drug!"

    The only thing that really matters these days is, "Who can we pay at the FDA to let us sell this?" We've truly returned to the days of snake-oil salesmen.

     

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    Anonymous Coward, Jun 6th, 2013 @ 10:25pm

    What seems to have been missed from the analysis is that the metric to determine drug effectiveness is to compare it against a placebo. Therefore, if the placebo effect (a psychological effect) is stronger now than it used to be, it could appear that drugs are less effective.

    There are a few reasons why the placebo effect could be stronger now, including greater trust in pharmaceuticals brought on by their success, particularly with antibiotics. If I take a drug now, I have 100% confidence that it has been researched, developed and correctly administered to cure what ails me. Whether that's true seems to be less relevent.

     

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    Anonymous Coward, Jun 6th, 2013 @ 10:38pm

    Re:

    If that was the case, the placebo effect should be weakening. If I took a modern drug, I'd be expecting it to keep me sick, not make me healthy.

    Dunno where you're getting all that confidence from. Are you not from the US? Over here we see commercials for legal firms on TV all the time, advertising for lawsuits against the pharmaceutical companies. "If you or a loved one have taken that medicine that came out last year, call the law offices of So-and-So. You may be entitled to a cash settlement." It's been like that for at least a decade.

     

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    horse with no name, Jun 6th, 2013 @ 10:48pm

    Amusing piece

    It's pretty fun to read this piece and see the author trying to justify the headline, all the while ignoring reality.

    Let's toss a few out there: drug resistance, desire to narrowly target the drug, minimizing side effects...

    Let's not forget the old "low hanging fruit" issue. 40 years ago, it was much easier to develop a new drug, there were large areas that had not been touched. There are plenty of reports out there that will tell you that the current drug technology will pretty much run it's course within most people's lifetimes, as the bacteria becomes more resistant, and as researchers realize that they are at the end of the line for developing new drugs in the current fashion.

    So nice try Tim, but perhaps you should get informed on the subject a bit before parroting someone else's "research".

     

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    Anonymous Coward, Jun 6th, 2013 @ 11:04pm

    Generic prescribing

    "It already has plenty of compliant doctors, paying customers and an exploitable patent system in its corner."
    Tim, most of what you right is excellent, but you've missed the mark here.
    Branded drug prescribing is way down while the rate of generic prescribing is steadily climbing. Generics now make up about 80% of all prescriptions in the US. Insurance companies regularly send physicians report cards based on their percentage of generic prescribing. Each Doc is kept aware of his/her position relative to both regional and national averages. Furthermore, the pharmaceutical companies no longer dole out any of the free trinkets or junkets that once poured out of their marketing departments. Yes there have been new regulations that have impacted marketing practices, but I think a lot of us in medicine suspect that no small part of the disappearance of pharmaceutical marketing is due to the fact that they just don't have anything really new or useful in their pipelines to replace numerous drugs that have gone off patent.

     

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    madasahatter (profile), Jun 6th, 2013 @ 11:27pm

    Drug effectiveness

    Some of the newer drugs are very effective as noted in the article. But many drugs seem to be for ailments that are more annoyances (erectile dysfunction) than serious medical problems (epilepsy, migraines) that can be disasterous for the patient. Drug companies seem to going after drugs that can make massive profits rather than drugs that can actually help patients.

     

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    Anonymous Coward, Jun 7th, 2013 @ 12:05am

    It's unfortunate that neither the write-up here nor the linked article actually provides a link to the paper in question, as I would have liked to see what it actually said. This is because claims like "They were, on average, 4.5 times as effective [than placebo]" sets off massive alarm bells to me due to the vagueness of the statement, in addition to knowing just how variable clinical trial endpoints are (even within the same therapeutic area). Claiming that all this data can be boiled down to a simple "x times more effective than placebo" suggests to me that either the linked article is taking some serious liberties with presenting what the paper actually says, or that the paper itself engages in a rather questionable meta-analysis that amounts to torturing the data until it confesses (to whatever conclusion they were aiming for).

    Add to this the fact that many (possibly most) Phase 2 and Phase 3 trials these days don't actually have a placebo arm (due to obvious ethical issues when the patients have serious diseases or conditions that need to be treated). Rather, the control arm of many clinical trials will be whatever the gold standard in therapy happens to be, with the endpoint being either non-inferiority or superiority to that gold standard. How does this study take into account those trials, or does it simply leave them out?

    I know the pharma industry is a rather popular punching bag (and I've got plenty of criticism I can level at the industry myself despite working in it), but it doesn't do anyone any good to simply parrot criticisms that may very well be based on a lack of understanding of the science involved, or in some cases even an intentional misrepresentation of the data.

     

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    DW, Jun 7th, 2013 @ 12:30am

    It's worse than that...

    ...when you consider A) the insane rate of retraction in medical journals and B) the fact that pharma companies get to withhold the results of negative trials.

    So you may have 4 trials that show no effect, and one that shows a small effect. You publish the one that shows the small effect and not the others... and then have it retracted ten years down the line when the patent runs out.

    Neat huh?

     

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    Anonymous Coward, Jun 7th, 2013 @ 12:44am

    Side Effects?

    Generally the trend with more modern medicine is fewer or lesser side effects even if it less effective than the older meds that are rougher on you. Effectiveness isn't everything, otherwise we'd all be taking our pain medication through syringes.

     

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    Anonymous Coward, Jun 7th, 2013 @ 1:08am

    Re: Amusing piece

    a) Drugs are not just to combat bacteria, but to increase/decrease levels of hormones and other substances in the body, tag cells, target specific cells in the body and other stuff those kind of things don't get to create "resistance" to anything.

     

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    M. Alan Thomas II (profile), Jun 7th, 2013 @ 1:18am

    Re: Re:

    Well, it might be from a four-year-old article in Wired:
    It's not only trials of new drugs that are crossing the futility boundary. Some products that have been on the market for decades, like Prozac, are faltering in more recent follow-up tests. In many cases, these are the compounds that, in the late '90s, made Big Pharma more profitable than Big Oil. But if these same drugs were vetted now, the FDA might not approve some of them. Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time.

    It's not that the old meds are getting weaker, drug developers say. It's as if the placebo effect is somehow getting stronger.
    http://www.wired.com/medtech/drugs/magazine/17-09/ff_placebo_effect

     

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  18.  
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    Anonymous Coward, Jun 7th, 2013 @ 1:38am

    why don't you talk about the natural resistance to drugs, and the evolution of condition and disease's, and resistance, and the tolerance to drugs but to not taking the entire course, particularly for anti-biotic drugs.

    As well as the progressive improvements in the reporting of specific effects of new drugs compared to what was performed in the 70's for example.

    For example VRE (Vancomycin Resistant Enterococci)

    or

    Vancomycin resistant Staphylococcus aureus

    HIV drug resistance occurs when microevolution causes virions to become tolerant to antiretroviral.

    The drugs ARE getting better, but so are the dieses.

     

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  19.  
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    Anonymous Coward, Jun 7th, 2013 @ 1:42am

    Re: nature vs man-made

    also tens of millions of years, and billions of people to evolve resistant and more aggressive disease's.

     

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    Anonymous Coward, Jun 7th, 2013 @ 1:43am

    Re: Amusing piece

    damn straight +10

     

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    Matthew Cline (profile), Jun 7th, 2013 @ 1:46am

    Re: Stating the Obvious

    What, medical pharmaceutical companies didn't realize that 40 years ago?

     

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    Anonymous Coward, Jun 7th, 2013 @ 1:52am

    Re: Side Effects?

    side effects and long term use effects, resistance, and a far higher level of standards that relate to these effects.

    how can you compare these kinds of things when years ago, there was no drugs at all for many of these conditions.

    There were no drugs for smallpox, malaria, HIV/AIDS, cervical cancer, stomach ulcers, so how can the efficacy of those drugs be compared to years ago, when there were no drugs to compare ?

     

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  23.  
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    Anonymous Coward, Jun 7th, 2013 @ 1:57am

    What we really need.

    We need to go back and become redneck engineers, for many that is anathema, scary and downright dumb, but for me is the only way people will actually get some healthcare in their life times.

    The problem, crazy regulation and monopolies create an environment where exploitative/abusive practices can flourish, is cheaper today to fly to New Zealand to have surgery than it is to have it in the US or Europe, it created an entire industry that people call healthcare-tourism, but even that is out of reach for many, further there are negative bias against subgroups that lead to less than optimal care, people discriminate against criminals, races, religion and just about anything they can think of, if you were a doctor would you treat a pedophile or rapist with great care? probably not, bias is hard to root out.

    So seeing how pirates work I realized that we shouldn't be trying to force anybody to give us care, we should instead be teaching people how to take care of themselves and create the know how on how to build and produce the things people need to achieve that so each and every person will be able in their own group to make it happen, that is the fucking best safety net everybody can have.

    Pirates don't depend on others to distribute anything, they can do it by themselves and they do it exceptionally well, pirates can defeat the most intricate "security features" created by people who you can say are literally rocket scientists or on par with them, meaning they actually have great understanding of the subject they pay attention to.

    Instead of pirating movies and exercising their brains on ways to hack "security measures" maybe is time to hack healthcare and start equipment local clinics everywhere with the tools they need to give first class care to everyone for free.

    Those clinics need cutting tools made of metal, how many people here know how to forge a knife?

    Could we use spinning-metal techniques to produce cheap functional stethoscopes out of an steel or aluminum can?
    How would we test if to see if they do what they are supposed to do?
    Using audio spectograms?

    Could people make scalpels out of aluminium cans?
    Chest spreaders for surgery?
    Gauze using wooden looms?
    How to test the metal after a pouring?
    I know people use gas spectrometry to test the composition of metals and CT-Scans to check integrity of the metal inside, but also sound testing that could catch brittle pieces since they sound different and can be viewed by a computer.

    Drugs can be produced too, basically drug producing is like cooking food, most drugs today are produced using engineered bacteria that then are "fermented" then tested to produce the desired substance which is them "distilled", then tested to be then tested again at the end.
    Most tests in chemistry are done by chromatography and mass spectrometry.

    How would we connect with others to see what they are doing and get feed back about stuff?
    Using something like "patientslikeme.com" that can predict how drugs test trials will come out before they are out?

    This is not pie in the sky, this is actually very doable, making things require knowledge on how to make it and how to test it to see if it is doing what is suppose to do it.

    And hacking healthcare actually could make life less scary for all of us.

    I would like to see big pharma drag a cancer patient to court for infringing their patents and the Judge ask the guy, why did you did it?.

    "Your honor, I had no money and no insurance, I would die without the drug and I found out how to make it by myself and it only cost me pennies, without those drugs I wouldn't be standing here today, so that is why I did it, because I wanted to live, I am sorry that my will to live override my obedience to the rules."

    Crowds can produce nearly every little bit doctors need to treat anybody, from gaze to CT-Scanners today.

    Maybe is time to start helping ourselves instead of begging for others to be sensible and have some empathy. Knowledge is unbiased it doesn't care who is using it, it doesn't discriminate against criminals, gays, religion, it doesn't care if you have insurance or not, it doesn't care if it is lawful or not, if it is right or wrong, those things people care, knowledge can be acquired by anyone, it is cheap, free and light but can change your life forever by freeing you to do it yourself when others try to negate anything to you.

    Did people know that there are only four or five classes of antibiotics in the world?
    You just need to produce five types of antibiotics to have everything a big hospital has.

     

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    Josef Anvil (profile), Jun 7th, 2013 @ 1:58am

    Its in the math

    Corporate greed and drug effectiveness are inversely proportional

     

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    Zakida Paul (profile), Jun 7th, 2013 @ 2:03am

    Make drugs less effective
    That keeps people sick/in pain for longer
    People need to keep buying the drugs
    Big Pharma profits big time

    It's all about the almighty dollar.

     

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    Anonymous Coward, Jun 7th, 2013 @ 2:19am

    Why cure someone when you can make them a slave to their product for life.

     

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    art guerrilla (profile), Jun 7th, 2013 @ 3:41am

    Re:

    1. Big Pharma spends MORE on marketing than they do on R&D, that really is as far as you need to go in being skeptical about their claims...

    2. on top of that, a LOT of so-called R&D money is actually bullshit marketing fluff in disguise: 'research' on whether viagra should be a blue or red pill; 'research' on whether you'd sell more if it was a caplet or a capsule, etc...

    3. these are NOT altruistic organizations working 24/7 to provide comfort and relief to the afflicted, these are soulless korporations whose SOLE purpose is to part you from your money...

    art guerrilla
    aka ann archy
    eof

     

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    Mr. Applegate, Jun 7th, 2013 @ 4:02am

    Re:

    I have been saying this for years. Anyone who looks at the history of drugs with an honest open mind can see it. With many of the newer drugs the side effects are often far worse than the initial problem the drug is meant to treat. The focus isn't on creating a better drug, it is on getting another patent and marketing the drug so patients will tell their doctors to write a script for that drug.

    Drug companies started focusing on profits over effectiveness long ago. Care to take a guess as to why? The article eludes to it. Health Insurance! Everyone (OK, many) thinks Universal Healthcare will be the cure to health care costs. It only exacerbates the problems. Health Insurance gives everyone the ability to pay almost regardless of what the costs are. Health Insurance makes people think they can go to the doctor with no real symptoms and demand an MRI or a prescription, after all the cost to them is minimal.

    Every time I go to the doctor he wants to give me some new drug. The main office I work in has a doctors office right across the parking lot. At least 3 times a week I see drug company reps taking in boxes of samples or new drugs AND lunch for the entire staff. I'm not talking Subway either.

    Advertising for drugs, at least to the public, should be illegal. The general public doesn't have the knowledge to be able to determine if a drug is the correct drug for them, but they see it advertised, or hear from word of mouth how 'great' it is and then they demand it from their doctor, if the doctor won't write the script, they just get another doctor who will.

    Bottom line is your right, it isn't about helping the people it is about the almighty dollar.

     

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    Anonymous Coward, Jun 7th, 2013 @ 4:07am

    Re:

    You do understand that a lot of drugs are not directed at bacteria, fungi or virus don't you?

     

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    Anonymous Coward, Jun 7th, 2013 @ 4:09am

    Re: Amusing piece

    It's pretty fun to read this piece and see the author trying to justify the headline, all the while ignoring reality.

    Let's toss a few out there: drug resistance, desire to narrowly target the drug, minimizing side effects...

    Let's not forget the old "low hanging fruit" issue. 40 years ago, it was much easier to develop a new drug, there were large areas that had not been touched. There are plenty of reports out there that will tell you that the current drug technology will pretty much run it's course within most people's lifetimes, as the bacteria becomes more resistant, and as researchers realize that they are at the end of the line for developing new drugs in the current fashion.

    So nice try Tim, but perhaps you should get informed on the subject a bit before parroting someone else's "research".


    I agree, though it's undeniable Tim's douchebag pill is working. I just hope he doesn't develop the same gynecomastia side effect that Masnick did taking that prescription.

     

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    special-interesting (profile), Jun 7th, 2013 @ 4:45am

    Another interesting article on the drug industry. A good angle too. Would like to see original references though. The side effects are worth considering also as some are important. Did the independent analysis include the common fact that antibiotics are becoming less useful as bacteria become resistant to them? If not then the study wold have more of an impact but otherwise still worth commenting on.

    Its common knowledge, for any who look, that for years drug firms try to re patent drugs or even just combine two drugs together, brand them with a new name, and sell them for 10 or more times the price of each separately. Both practices should be banned.

    Its also true that many if not most medical drug discoveries are molecules made by nature. (however currently synthesized) Its been a while since a new pain reliever with less side effects became available and surely big Pharma has tried.

    It would not be surprising to hear that the continual new drugs that pharmaceutical companies are stuck with today are not as effective as their effective advertisement campaigns claim they are. It rings true in respect to common high power ruthless marketing techniques; Crush the competitors and dilute the knowledge base of the masses with mush.

    Will the fact that some consumers/doctors made less effective and more costly choices make them liable for possible health issues related to an inferior product? Did this study identify them specifically and compare side effects also?

    'Independent' medical research has been corrupted by corporations before (remember what the Tobacco industry did to invent the term “cigarette lie/argument”) and although its nice that an Independent Research Institute is currently functional with some critical review process... how long will they last? They will likely need public support to survive.

    There have been a lot of new cancer drug/treatments that seem to be promising we still have the extremely draconian chemotherapy in use. Its hard to keep in mind that there is no profit in a total cure. Treatment is profitable and there is a huge, really huge, industry that depends on that alone.

    Given that the pharmaceutical industry depends on Hollywood Accounting Principles to survive it a good bet that we have smoke... and a fire probably not far away. It takes time to devise a sales marketing solution to maximize profits. And. Once they make it to the market; What price will be levied?

    A very cynical opinion for sure but the only thing that American/world industry can be trusted with is to be ruthless beyond life, health and liberty. (certainly the US Constitution was no big deal to get rid of)

    Big pharma is a effective monopoly of a few large companies dominating the market. This monopoly is enforced by the DEA and the FDA with their almost totally imaginary international trade quality fears. What we need instead of some large cold heartless corporation owned drug stores is a good local apothecary.

    High prices kill people in the same way as no treatment at all. Witch doctors and blood letting might be better than the current system.

     

    reply to this | link to this | view in thread ]

  32.  
    identicon
    quawonk, Jun 7th, 2013 @ 4:49am

    If you only have to take one pill to cure your cold, they make money on one pill. If you have to take two or three pills, they've just doubled or tripled the money they made from you.

    Not rocket science.

     

    reply to this | link to this | view in thread ]

  33.  
    identicon
    Anonymous Coward, Jun 7th, 2013 @ 5:00am

    Re: Re: Stating the Obvious

    "Is that necessarily true . . .?"

    All indications say yes.
    How many decades has it been since the last cure was publicly available?

    Open research? - What are you, a commie red basturd?
    The job creators need astronomical profits hidden off shore in order to provide minimum wage no benefit jobs for all us yobs. They call it the jobs for yobs program.

     

    reply to this | link to this | view in thread ]

  34.  
    identicon
    Anonymous Coward, Jun 7th, 2013 @ 5:03am

    Re:

    and there is no war on generics, doctors are not bribed and there really is a santa claus.

     

    reply to this | link to this | view in thread ]

  35.  
    identicon
    Anonymous Coward, Jun 7th, 2013 @ 5:05am

    Re:

    My favorite possible side effect is oily discharge.

     

    reply to this | link to this | view in thread ]

  36.  
    identicon
    Anonymous Coward, Jun 7th, 2013 @ 5:12am

    Re:

    "the placebo effect (a psychological effect) is stronger now than it used to be"

    This is really weak. Not only did you not provide any substantiation for your hypothetical claim, but even if it were supported by data the conclusion is based upon a casual correlation. May I remind you of the graph which shows a decrease in pirates vs an increase in global temperature.

     

    reply to this | link to this | view in thread ]

  37.  
    identicon
    Anonymous Coward, Jun 7th, 2013 @ 5:17am

    Re: Amusing piece

    Ahhhh, the good old days. Yup - things were so much easier then. Garage doctors brewed up miracle cures thus saving humanity from plague and disease.

     

    reply to this | link to this | view in thread ]

  38.  
    identicon
    Anonymous Coward, Jun 7th, 2013 @ 5:18am

    Re:

    So are spell checkers

     

    reply to this | link to this | view in thread ]

  39.  
    identicon
    Anonymous Coward, Jun 7th, 2013 @ 5:44am

    Heart Meds won't kill you due to arsenic poisoning....and you say that's less affective?

     

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  40.  
    identicon
    Matt, Jun 7th, 2013 @ 7:30am

    Bad Pharma

    If you want more in depth coverage of this, you should read Ben Goldacre's book 'Bad Pharma'. In it he goes into a lot of these shenanigans perpetrated by the pharmaceutical industry.

    The fundamental question is not only are drugs getting worse compared to placebo, but why we test against a placebo at all. For most new drugs there is already a medically accepted alternative in place. For example, if you have a new headache pill the real world choice is not should I take this new pill or do nothing. The choice should be should I take this new pill or take an aspirin.

    -Matt

     

    reply to this | link to this | view in thread ]

  41.  
    identicon
    Anonymous Coward, Jun 7th, 2013 @ 7:44am

    Re: Generic prescribing

    "A generic drug must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use"

    I know at least here in Australia, the Doctor just prescribes the actual drug, like Codeine, then when you go to the Chemist, if there is a generic equivalent, he asks you if you prefer the origan or are happy to accept a generic.

    The choice is not the Doctors, he just prescribes the drug he has decided for you, you get to choose if you would like to pay a little less for a generic, as you are fully aware that the generic drug is by law exactly the same, contains the same active ingredient, and as described about is exactly the same as the brand name.

    My research shows this applies also to Doctors in the US.

    By law a generic is exactly the same as the original, no better no worse, EXACTLY THE SAME.

    By definition if it is not exactly the same it is a derivative drug, and it is not generic.

    Generic drugs are made and sold a lot more cheaply because THEY ARE EXACTLY that same, and as such can use the original clinical trials, testing and evaluation as the original drug.

    If it is different, it has to go through it's own set of testing and trials, and is therefore not generic, but a new product, generic companies do not have the resources to perform pre-clinical trials, clinical trials, and regulatory approval to market the drugs.

    Nor, do generic companies have to accept the very high attrition rates of new compounds.
    about 1 in 10,000 chemical compounds identified to treat a disease will be approved for marketing.

    a study in 2006 showed that the cost of development of a new compound to marketing stage is between $500 million and $2 billion dollars.

    Journal Health Economics in 2010 estimated approx. $1.2 Billion.

     

    reply to this | link to this | view in thread ]

  42.  
    identicon
    Anonymous Coward, Jun 7th, 2013 @ 8:04am

    Re:

    are you accusing Masnick, Timbo and others at TechDirt of misrepresentation ?? ... if not, why not.

    you raised some very valid points too I might add.

    also are they repeating the original drugs clinical trials, or just using historical records, and how do they account for drugs there simply were not available or had not been developed in the 70's ?

    The people who 'write' for TD are not interested in unbiased 'reporting' of the facts, they are looking for "the hook", the catchy headline (some would call it 'click bait'), not boring, messy 'FACTS'!!!

    that amounts to torturing the data until it confesses (to whatever conclusion they were aiming for).

    Love that line !!!!

     

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  43.  
    identicon
    Anonymous Coward, Jun 7th, 2013 @ 8:09am

    Re: Re:

    How about rectal leakage? Or, "in rare cases, death".

     

    reply to this | link to this | view in thread ]

  44.  
    identicon
    Anonymous Coward, Jun 7th, 2013 @ 8:13am

    Re: It's worse than that...

    B) the fact that pharma companies get to withhold the results of negative trials.

    1 in 10,000 chemical compounds identified to treat a disease makes it to market, that means 9,999 resulted in "negative" trails.

    I can understand that there is no need to prove a negative, and it would be an unnecessary burden to product the results of every negative experiment, and stupid.

    example HPV vaccine, research was started in the mid 1980's for the vaccine, US FDA approved the first preventive HPV vaccine in 2006. People could of spent their entire career working on this one vaccine, and you are saying the price for the development and approval of this drug is high ??

    You don't think 20 years of development would be expensive ?

    Or that a HPV vaccine is not something that has saved many thousands of lives ?

     

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  45.  
    identicon
    Anonymous Coward, Jun 7th, 2013 @ 8:18am

    Re: Re:

    di·e·sis

    noun, plural di·e·ses

    Origin:
    1350–1400; orig., any of several musical intervals smaller than a tone (for which a double dagger was used as a symbol); Middle English < Latin di ( h ) esis < Greek díesis literally, a sending through, equivalent to die-, base of diïénai to send through ( di- di-3 + hiénai to send) + -sis -sis

     

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  46.  
    identicon
    Anonymous Coward, Jun 7th, 2013 @ 8:33am

    Re:

    Its also true that many if not most medical drug discoveries are molecules made by nature.

    All molecules are made by nature, even ones that come out of a test tube. All molecules are made of elements, all elements are 'natural'.

    just as natural, as Einstein's E=MC2 equation, it's the product of nature, it's also the natural property of someone's intellect !!!

     

    reply to this | link to this | view in thread ]

  47.  
    icon
    John Fenderson (profile), Jun 7th, 2013 @ 9:04am

    Re:

    If I take a drug now, I have 100% confidence that it has been researched, developed and correctly administered to cure what ails me.


    But I sure don't, and most of the people I know don't. Skepticism is particularly high with the newer drugs.

    Still, it's an interesting point. I wonder if anyone's studied the overall confidence people have in the safety and efficacy of drugs?

     

    reply to this | link to this | view in thread ]

  48.  
    identicon
    DW, Jun 7th, 2013 @ 11:50am

    Re: Re: It's worse than that...

    No that's not what I meant.

    You do five or six trials on the SAME product, and only report the ones that show a positive result.

    You are referring to something completely unrelated.

     

    reply to this | link to this | view in thread ]

  49.  
    icon
    bytes (profile), Jun 7th, 2013 @ 1:10pm

    Yes new drugs have come along way

    But the side effects of many of them read like a book, and many new drugs the side effects are worse than the original reason for the drug treatment. You have new drugs that can cause cancer, blindness, cause the heart to stop, cause uncontrollable tics and some are tics are violent and not reversible after the drug has been stopped. Your stomach can bleed, your blood pressure can sky rocket, you can have seizures. Take for instance diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. So either way you can have heart problems. So next time your Doctor writes you a prescription ask your Doctor, what are the side effects then be sure to ask the Pharmacist as well. Some Doctors don't know all of the side effects because the newer drugs can have a multitude of them. Now add "Less effective" and you really have to ask yourself if the newer drugs are worth the price and the side effects associated with them.

     

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  50.  
    icon
    dennis deems (profile), Jun 7th, 2013 @ 1:31pm

    Re:

    Why would the placebo effect be stronger in 2010 than it was in 1966? That doesn't make any sense.

     

    reply to this | link to this | view in thread ]

  51.  
    identicon
    horse with no name, Jun 7th, 2013 @ 5:36pm

    Re: Re: Amusing piece

    More like "we had nothing before, and then someone discovered penecillin". The difference there would be huge, as people were not expecting drugs to do anything, so a placebo would have little effect.

    Today, we are trained to "take a pill and get better" so the placebo effect would be huge. Under the right circumstance you can sell lead as gold, right?

     

    reply to this | link to this | view in thread ]

  52.  
    identicon
    Anonymous Coward, Jun 8th, 2013 @ 2:47am

    Re: Re: Amusing piece

    This is not the good ol' days, this is actually the new order.

    Distributed healthcare.

    It become cheaper to actually manufacture and produce the things you need than to "buy" it.

    Computer miniaturization has come a long way and you can actually produce almost any drug in your kitchen and you actually can test it to see if it is good or not.

    If people have to pay for million dollar treatments sure they can buy million dollar equipment.

     

    reply to this | link to this | view in thread ]

  53.  
    identicon
    Anonymous Coward, Jun 8th, 2013 @ 4:30am

    Re: Re: Re: Amusing piece

     

    reply to this | link to this | view in thread ]

  54.  
    identicon
    Anonymous Coward, Jun 8th, 2013 @ 4:40am

    Re:

    The monopoly is enforced first and foremost by patents and by secondary means like legislation banning old drugs or practices forcing everyone to use only one or generously allowing some older drug or practice to continue as long as it can achieve certain thresholds, when that can't be done go out and just outright buy the competition and say to them we will pay you to not produce something, it works because there are so few generic manufacturers.

    Funny how that works.

     

    reply to this | link to this | view in thread ]

  55.  
    identicon
    Anonymous Coward, Jun 8th, 2013 @ 4:46am

    Re: Re: Re: Amusing piece

     

    reply to this | link to this | view in thread ]

  56.  
    identicon
    Anonymous Coward, Jun 8th, 2013 @ 9:35am

    Re: Re: Re: It's worse than that...

    that would be testing the compound against DIFFERNT conditions, finding out what problems that drug can help with if any.

    So you would expect there to be much testing for conditions that are not helped by this compound, and you would expect the drug companies to accept that, and not have to say that "aspirin helps headaches, but does little in promoting bone growth in a broken arm".

    So for Aspirin they would test it's efficacy for a range of conditions, and by a process of elimination and selection would then be able to determine, what conditions are assisted by this new compound.

     

    reply to this | link to this | view in thread ]

  57.  
    identicon
    Anonymous Coward, Jun 8th, 2013 @ 9:38am

    Re: Re: Re: It's worse than that...

    also, how are they supposed to know before they test for it what the new compound does ? You say there is much unnecessary testing, but I say it is necessary for them to determine what (if anything) it is good for.

    A negative result is a positive result as it helps to exclude (or include) what the compound does (or does not do).

    Without that testing, (and negative results) you have no way of knowing if it is good for something else, or for that!! for that matter.

     

    reply to this | link to this | view in thread ]

  58.  
    identicon
    Anonymous Coward, Jun 8th, 2013 @ 9:39am

    Re: Re:

    yes

     

    reply to this | link to this | view in thread ]

  59.  
    identicon
    Anonymous Coward, Jun 8th, 2013 @ 9:43am

    Re: Re:

    I have been saying this for years. Anyone who looks at the history of drugs with an honest open mind can see it

    Next thing you say !!!!

    With many of the newer drugs the side effects are often far worse than the initial problem the drug is meant to treat.

    Where did you get that from, from your honest open mind ??

    THEN THIS GEM:
    The focus isn't on creating a better drug, it is on getting another patent and marketing the drug so patients will tell their doctors to write a script for that drug.


    Again, this is from an honest, open mind ?

    Honest, open but with no basis in fact, or reality.

     

    reply to this | link to this | view in thread ]

  60.  
    identicon
    truth sometimes hurts, Jun 8th, 2013 @ 1:26pm

    Re: What we really need.

    No we don't need to add more drama to our lives we have plenty. We need to get serious about what we eat, our health, live close too, work, and plan our priorities better. We have four times the crap in our lives than our parents had. Tech is getting organized, and less morals is the norm in some areas. People in some areas are getting d-synthesized to life around them even if their life around them sees brutality on a regular basis. When money trumps life itself then we are heading towards a life no better than a ruthless lion on the prowl for prey. We become the prey, but we have lions among us. What kind of life will be leaving behind for our generations to come? Big Pharm is the lion, but so is our healthcare system when they are permitted to choose who lives, and who dies.

     

    reply to this | link to this | view in thread ]

  61.  
    identicon
    Anonymous Coward, Jun 9th, 2013 @ 2:27am

    Re: Re: Re: Re: It's worse than that...

    Are you being purposefully dense for any reason in particular?

    How will you know if something is good or bad if the idiot trying to get approval hides all the bad results from the testing?

     

    reply to this | link to this | view in thread ]

  62.  
    identicon
    Anonymous Coward, Jun 9th, 2013 @ 2:28am

    Re: Re: Re:

    So you know you are full of shite and will still go down that route?

     

    reply to this | link to this | view in thread ]

  63.  
    identicon
    Anonymous Coward, Jun 9th, 2013 @ 2:30am

    Re: Re: What we really need.

    So you will continue to ask the Lion to not eat you?

    I rather go make a spear to keep the Lion away.

     

    reply to this | link to this | view in thread ]

  64.  
    identicon
    Anonymous Coward, Jun 9th, 2013 @ 2:34am

    Re: Re: Re:

    Are you saying drug companies don't use those tactics?

    Are you saying the NY Times lied about their articles on big pharma modus operandis?

    Are you saying that all those, paid for by pharma companies, big events are not there to be used to make doctors use their drugs?

    Are you saying that kickbacks to doctors for sales doesn't happen?

    Are you saying that hospital administrators are not target by sales people?

     

    reply to this | link to this | view in thread ]

  65.  
    identicon
    Anonymous Coward, Jun 9th, 2013 @ 2:35am

    Re: Re:

    Not all of them, there are many artificial compounds produced by artificial means.

    Are you trying to be deliberate stupid or something?

     

    reply to this | link to this | view in thread ]

  66.  
    identicon
    Anonymous Coward, Jun 9th, 2013 @ 5:19am

    Re: Re: What we really need.

    I believe we need a lot more drama, you can go talk to the nice lion there, I am going to find a stick to fashion me a spear.

    This is the difference between the people who have the knowledge and people who don't.

    You can wail your arms all you want that nice lion there still gonna eat you, on the other hand the dude with the spear probably will eat the lion tonight.

    The spear in healthcare is the drugs and instruments,

    A person who knows how to, can make a dialysis machine from scrap to save a life.
    BBC: 'DIY' kidney machine saves girl

    or print a piece of plastic to safe yet another life.

    NPR: 3-D Printer Makes Life-Saving Splint For Baby Boy's Airway

    Knowledge is the spear, kill the lion or wail your arms at it, you choose.

    I want more drama, I want more knowledge, but I will not force you to do it, you have to chose, you have to be the one responsible for taking the path you need and you need to deal with the consequences of those choices.

     

    reply to this | link to this | view in thread ]


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