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Alex, I have lived in more than one country, so I have made specific observations of precisely how little influence the FDA has on the drug regulations of other countries. And I previously provided numerous examples to you of the FDA keeping drugs off the market or removing drugs from the market based on evidence of safety and effectiveness.

http://news.ycombinator.com/item?id=4245571

I would submit that the underlying system corruption is probably stronger among enterprises that sell schedule I controlled substances here in the United States than among those that sell government-regulated, physician prescribed medications. Both regulatory systems, the system that makes some drugs I've seen you speak up for contraband, and the system that makes some newly invented drugs legal items of commerce, may indeed need further reform. But it's an exaggeration (contradicted by thoughtful comments by drug industry researchers who have already posted replies in this thread) to say that the enterprises that develop new drugs for prescribed medical treatment are corrupt in general beyond what Goldacre claims with specific evidence.

"But it's an exaggeration [...] to say that the enterprises that develop new drugs for prescribed medical treatment are corrupt in general beyond what Goldacre claims with specific evidence."

edit: Response moved to pastebin: http://pastebin.com/cniysd82

(Didn't realize how long that was going to get.)

You've damaged this comment page and shown your immaturity to the public.

I think you're being dramatic. Posting a too long comment in trying to make a point?

He posted an extremely well researched, cited and thoughtful response. He did not resort to namecalling or logical fallacies. Your response is to call him names. Who is immature?

Most of your points pertain to placebo controlled trials of antidepressants. No argument there... it's a very difficult area ripe for abuse. I wouldn't however use this as justification that all trials of all drugs are rubbish.

Your arguments regarding non psychiatric medicines are weaker. For example, in oncology trials you state that the practice of excluding patients who are elderly or frail is 'not a good way to find out how to treat most cancer patients.' The reality is that it is very difficult to show any evidence of benefit in patients that aren't fit to start off with. This is because not being fit is a strong determinant of poor outcome. If you include them in the trial then it will be negative, and even those patients who might benefit won't ever get the treatment. This isn't bad science, it is just the required degree of pragmatism when resources for running trials are scarce. The way the research is done in reality is first you give the drug to the people most likely to benefit, and then if it works for them, test it in other groups less likely to benefit by running trials specifically in the elderly or frail groups. When these trials don't exist, and they often don't, the oncologist discusses the options with the patient and family based on the available evidence. They don't, as you seem to imply, give chemotherapy to everyone that walks in the door because Pfizer took them to lunch.

So definitely agree for antidepressant trials. But not for everything else. Although I haven't read Ben Goldacre's book. Yet.

"This is because not being fit is a strong determinant of poor outcome. If you include them in the trial then it will be negative"

I think this would be an extremely valid argument, except for the fact that these drugs are in fact targeted at, and mainly used by, the population that is older and more frail. And this doesn't just apply to cancer drugs, it applies to NSAIDs and all sorts of other garden variety treatments. I realize there are limited resources, but the end result is that the vast majority of the elderly (by far the biggest consumers of drugs) are taking medicines that have never been tested for safety or efficacy in people like them.

Also, it's not just SSRIs. There are a wide range of psychiatric and non-psychiatric drugs that are either no more effective than placebos or generics: SSRIs, benzos, ADHD drugs, anti-psychotics, statins, calcium-channel blockers, evergreens like nexium and clarinex, claritin, COX-2 inhibitors (now pulled from the market), etc.

Of the 20 most-prescribed drugs overall, it looks like just under half are no more effective than placebos or generics.[1] And if you look at the top 25 psychiatric drugs, something like 22 or 23 of them are no more effective than placebos or generics for longterm use, which is the vast majority of the usage.

[1] Statins are arguably useful for people who have already had a heart attack, but the vast majority of people taking them don't fall into this category, and it's not even clear whether they're really helpful for people who have had one. Meanwhile, longterm use basically causes at least mild dementia and muscle problems in everyone, meaning there is a negligible chance of benefit that's vastly lower than the benefit from giving up smoking or even moderate exercise, whereas there is basically a 100% risk of harm. Also, there is zero evidence that the new statins are better than the old statins, so even if you believe that statins are effective then my original argument still stands since there's no evidence that they're better than the generic ones.

Alex, I have lived in more than one country, so I have made specific observations of precisely how little influence the FDA has on the drug regulations of other countries.

That's beside the point.

The same trials that are used as the basis for product license applications to the FDA are used for license applications to the UK's MHRA.

The process of generating an approval and granting a product license is different, but the same data feeds into the process, giving rise to similar outcomes.

(Also: please do not confuse controlled substances with prescription-only medicines. Two different sets of law apply, one superimposed on top of the other, just to add to the confusion.)

At risk of resorting to an appeal from authority, I speak as a retired pharmacist: the process of obtaining product licenses for pharmaceuticals isn't so much broken as it's irrelevant, because as long as the submission relies on data that can be massaged by the applicant (who stands to profit from it), the outcome will reflect the inputs. (In other words: garbage studies go in, questionable product licenses come out.)

Please delete it. Post a link to it, but don't post the entire thing.

Woah, you're way off when talking about sciencebasedmedicine.org. That's Steve Novella's site - and he's about as respected as you get in the sceptic community. If you want to claim that it's mostly industry propaganda, you'd better have some good evidence to back up the claim!

"He's about as respected as you get in the sceptic community"

Ever look up how respected skepticism is within the larger philosophical community?

I mean look at my pastebin post: http://pastebin.com/cniysd82

And this encompasses only a small fraction of the corruption within the pharmaceutical industry, because I wanted to make it readable. There are literally dozens of book published on this.

But does SBM actually address any of the criticism? Not a single point of it, because there is no defense; in fact, it's all coming from high-level 'insiders' in the medical community -- JAMA, NEJM, the IOM, etc. Instead they just spin it in order to trick people who are predisposed to have faith in modern medicine. (And I use the term faith, because if you're familiar with these issues then it's unmistakably clear that this is really what it is.)

What science-based medicine does (again, the blog, not the concept) is really no different than what the evangelical megachurches do, it's just dressed up in different language.

Honestly, a lot of the points you make about SBM (the blog) are quite disturbing to me, as it is one of my primary resources as a lay-person to keep up with developments in woo, quackery and general commentary on popular medical reporting.

I hope you don't see these questions as confrontational because I genuinely would like to be pointed in the right direction for the some of these claims. (speaking as a relatively liberal person who recently joined a host of strongly conservative forums to get a picture of "the other side"...)

> Ever look up how respected skepticism is within the larger philosophical community?

I gather this means that it's not respected? Why is that? I find it hard to believe that scientific skepticism (and not the truther/birther/moon-landing-was-a-hoax kind) can find widespread opposition in any sort of critical thinking community.

> Instead they just spin it in order to trick people who are predisposed to have faith in modern medicine.

Are there any examples of this from the blog? I was (and am) under the impression that a lot of writing is backed up by fairly solid reasoning, references and such.

> What science-based medicine does (again, the blog, not the concept) is really no different than what the evangelical megachurches do, it's just dressed up in different language.

How so? This analogy sounds suspiciously like fundamentalists' claims of "scientism" and "science is just another religion!". If you mean something else, then do elaborate.

"I gather this means that it's not respected?"

Firstly, skepticism is basically just a new name for a discredited philosophical movement called 'logical positivism', in the same way that intelligent design is basically just a new name for creationism.

The section on positivism here has a brief summary:

http://plover.net/~bonds/nolongeraskeptic.html

I'm not sure where the best place to go for information on this would be though to be honest. Wikipedia has a brief article also but it's not especially helpful: http://en.wikipedia.org/wiki/Logical_positivism

"Are there any examples of this from the blog?"

- "It turns out that physicians view pharma funding sources negatively"

When there is disclosure that the studies were pharma funded. Often times this isn't disclosed even though it's supposed to be. Additionally, it's been proven beyond a doubt that pharma reps, dinners, gifts, etc. influence doctor's prescribing habits, but this is never mentioned, even though the point of the blog post is supposedly to show that it's rare for doctors to be under the influence of pharma.

- "On the other hand, this study also made me wonder if perhaps we place too much confidence in research funded by the NIH. [...] NIH funding is not a guarantee of quality science by any means."

Again the research unambiguously shows that pharma-funded research is vastly for more likely to find positive results for the drug in question than NIH research.

- "For example, a recent study found a correlation with government funding of a trial and positive results, and another study found no higher likelihood of positive outcomes in industry-sponsored trials but a higher likelihood of reporting double-blinding"

Even when he mentions that pharma sponsored studies are 'associated with' increased likelihood of favorable results, he cites one or two minor studies instead of the most important meta-studies on this topic.

- "Moreover, several studies have suggested that from a methodological standpoint industry-funded studies published in peer-reviewed journals are of equivalent or higher quality than clinical trials funded by other mechanisms."

Citation needed.

- "This is not surprising, given that many clinical trials funded by pharmaceutical companies are done for the purpose of winning FDA approval for a drug, either initially or for expanded indications, and the FDA has stringent requirements for these clinical trials."

So what he's really saying is that he's comparing apples and oranges.

- "Indeed, as I mentioned, this NEJM study doesn’t tell me anything that I didn’t already know"

The classic tactic of claiming that everything negative isn't important because it's 'something we already knew'

- "I’ve come to the conclusion that most doctors, at least in this sample, probably have it about right or may even be a little more skeptical of pharma than necessary."

You've got to be freaking kidding me. Again, look at the list of the most prescribed drugs, both psychiatric and non-psychiatric. And then look at what percentage of those are actually better than placebos or generics.

> "If you mean something else, then do elaborate.

In this case I was kind of referring to how preachers will get up on stage and do the gish gallup as an attempt to discredit evolution, as well as using emotional arguments and emotional tricks rather than facts or logic.

I generally do think that a lot of science falls into the category of scientism, but that isn't what I was getting at here. I also generally think there are good reasons for considering science to be a religion, but that's also not what I was getting at.

>Firstly, skepticism is basically just a new name for a discredited philosophical movement called 'logical positivism', in the same way that intelligent design is basically just a new name for creationism. The section on positivism here has a brief summary: http://plover.net/~bonds/nolongeraskeptic.html

That doesn't really shed any light. It merely asserts, without proving, that the modern skeptic movement is equivalent to logical positivism, and provides neither an argument for that, nor an argument against logical positivism. Now, I'm familiar with Popper and Quine's criticisms of logical positivism, and there are other criticisms that I'm probably not aware of, but I don't see how those criticisms relate to the modern skeptic movement.

By the way, I do agree with many of the criticisms of the modern skeptic movement from that link, but I don't think that most of it has anything to do with whether the skeptics are correct in criticizing certain treatments and advocating others.

> Ever look up how respected skepticism is within the larger philosophical community?

I'm a little unclear on what point you're trying to make here. Can you clarify?

> I mean look at my pastebin post: http://pastebin.com/cniysd82

I took a look at your pastebin post. There are a lot of criticisms there of various kinds of bad practices, but not all of them have anything to do with whether the medicines actually work. For instance, the patent issue; while that's a fair issue in its own right, whether large pharmaceutical companies can prevent people from making generic equivalents by using patents does not affect whether the drug works or not. Or direct to consumer advertising; again, it may be a bad idea, but it doesn't have anything to do with whether the drugs actually work.

Many of the other criticisms here are fairly hypothetical. Yes, there are places where the system isn't ideal, where there's potential for the wrong incentives. There are places where it would be nice to do research that covered a broader spectrum. But that doesn't mean that it's all invalid. We live in an imperfect world. We should try to fight those cases when we can, try to get better results, but you shouldn't write off the entire industry merely because it's imperfect.

Here's another example. In the software industry, I see bad practices all the time. People not writing unit tests, not doing full regression tests, writing sloppy code that doesn't handle all of the error conditions, and so on. And yet, somehow, we manage to get by. Software generally works, it does what it says, it improves whatever it was setting out to improve. Sure, there are some big expensive failures you can point to. Sure, it would be nice if we did a better job at this, and should try to continue to fight for higher quality software. But just because there is some software imperfectly written doesn't mean that you should just write off the software industry.

> But does SBM actually address any of the criticism? Not a single point of it, because there is no defense; in fact, it's all coming from high-level 'insiders' in the medical community -- JAMA, NEJM, the IOM, etc.

Really? I just decided to take a look at SBM; I wasn't familiar with it before this thread, but decided to take a look at it. Here's an article on reducing prescriptions for elderly patients, because they may do more harm than good: http://www.sciencebasedmedicine.org/index.php/how-do-we-avoi... (addressing one of your concerns about differences in how medications effect the elderly). Or here's an example where they do address one of the concerns that you mention; they demonstrate that doctors actually are more skeptical of research funded by the pharmaceutical industry: http://www.sciencebasedmedicine.org/index.php/news-flash-doc....

> Instead they just spin it in order to trick people who are predisposed to have faith in modern medicine. (And I use the term faith, because if you're familiar with these issues then it's unmistakably clear that this is really what it is.)

You know, I do tend to be skeptical of pharmaceutical remedies, and so try to minimize them myself. But to say that you have to have faith to buy into modern medicine is a bit of a stretch. How do you explain ever increasing life expectancies? Clearly, there is something going right in modern medicine.

> What science-based medicine does (again, the blog, not the concept) is really no different than what the evangelical megachurches do, it's just dressed up in different language.

Citing actual scientific studies, which may be flawed in certain ways, is the same as merely preaching mythology from a 2000 year old book based on no science whatsoever? Remember, "science" is not some binary thing, where if there's one flaw, it's all false. It's a process, by which we attempt to come up with better models of the world, and try to reduce bias in the process. Sometimes there will still be some bias; you won't necessarily be able to eliminate it all. But that doesn't mean it's worthless.

There are definitely a lot of ways in which I wish that pharmaceutical research would be improved; but the fact that there are people now who are living perfectly normal lives while HIV positive with anti-retroviral therapies, when just 10 or 20 years ago they would have died of the same disease, leads me to believe that it's not all bad. I wish those drugs were cheaper, that they weren't so tied up with patents, and so on; but you know, I wish I had a pony too. To equate the research and development that went into such life-saving measures as equivalent to an evangelical megachurch is quite frankly ridiculous.

"not all of them have anything to do with whether the medicines actually work."

That's because in general I'm only interested in systemic problems, not specific case studies. There are entire books written about just anti-depressants, or statins, or whatever, which you can easily find on Amazon.

"How do you explain ever increasing life expectancies?"

Of the 30-year increase in life expectancy over the last 100 years, 25 years has come from better public health (e.g. sanitation), and another 1.5 years has come from preventive care like vaccination.

Source: Bunker JP, Frazier HS, Mosteller F. Improving health: measuring effects of medical care. Milbank Quarterly 1994;72:225-58.

lambda asked the same question I had, which is, simply: what is the point you're trying to make? You're making a lot of side comments about minor points, but I'm not sure what your thesis is.

> That's because in general I'm only interested in systemic problems, not specific case studies. There are entire books written about just anti-depressants, or statins, or whatever, which you can easily find on Amazon.

What is the point that you are trying to prove? Are you merely trying to demonstrate that there are certain systemic problems? If so, then congrats, you've won, there are some systemic problems. I don't think there has ever been a wide-scale system involving humans that hasn't had a certain amount of cheating, lying, corruption, and the like. If someone tried to claim to me that there was an entire multi-trillion dollar industry that did not involve some amount of cheating, lying, and corruption, I would laugh in their face.

Are you trying to argue that the pharmaceutical industry has a net negative value; that it it something that causes more harm than good? Because that's going to be a lot harder to prove, and a bunch of little anecdotes does not make a good argument.

You seem to be fairly concerned with certain people, who discuss science based medicine, and say that they are corrupt because they advocate for modern pharmaceuticals and criticize certain alternative medicine. Your evidence seems to be that they do not talk about all of the corruption and problems that you would like them to talk about. Do you have anything more than that?

> Of the 30-year increase in life expectancy over the last 100 years, 25 years has come from better public health (e.g. sanitation), and another 1.5 years has come from preventive care like vaccination. > > Source: Bunker JP, Frazier HS, Mosteller F. Improving health: measuring effects of medical care. Milbank Quarterly 1994;72:225-58.

Hmm. That's an 18 year old source, talking about life expectancy, which is a trailing indicator. So, 25 years of life expectancy from better public health (like sanitation and nutrition) is an amazing thing. And you say that 1.5 years come from preventative care like vaccination, and dismiss the other 3.5 years. Now, 3.5 years may not sound like much out of about 75. But think about it for a bit. 3.5 years is averaged across the whole population. Not everyone has a condition that is treatable; many people die of old age, accidents, murder, suicide, and things that modern medicine has not yet made much progress in. Those 3.5 years don't really affect any of those folks. So lets say that 1 in 10 people have a treatable condition (I'm pulling this number out of my ass, by the way; this is just a hypothetical, and the numbers may differ, in which case you would scale the reasoning appropriately). That means that those 1 in 10 people have gained 35 years of their life from medicine. Look around at your family and closest friends. How much would you trade for 35 more years with one of them?

So, you are discounting 18 years of medical progress, as well as treating a few years of life expectancy gained as no big deal. And of course, any talk of life expectancy also ignores quality of life issues; curing something that would have been crippling but not deadly doesn't substantially affect life expectancy, but does affect quality of life.

It sounds like you are trying to argue against the value of modern medicine, which is going to be a tough thing to convince people of, given all of the demonstrable benefits it has. I can understand discussing specific criticisms, and trying to figure out how we can improve it, and that saying "all medicine is scientific progress and is great" is fallacious, but trying to prove that modern medicine has a net negative value because of a few issues of systemic corruption is not the way to do it.

> What is the point that you are trying to prove?

I was arguing against the following statement: "But it's an exaggeration [...] to say that the enterprises that develop new drugs for prescribed medical treatment are corrupt in general beyond what Goldacre claims with specific evidence."

Or, more generally, reminding people why it is that our infrastructure is falling apart and why the federal government is at risk of collapse in the next few years, which are both in large part due to the massive amounts of fraud in the medical system. At least a third of all medical spending is waste and fraud, and that's not even counting the damages from all the needless harm it inflicts on people. Even just fixing some of the low-hanging fruit would leave us with enough money to provide healthcare to all Americans, as well as build an entire nationwide highspeed rail network every single year.

> Your evidence seems to be that they do not talk about all of the corruption and problems that you would like them to talk about.

It's mostly the intellectual dishonesty in virtually every single post that bothers me. The entire point of the blog is to 'prove' that alternative medicine is inferior to mainstream medicine because it isn't supported by science. They do this by looking at all the ways alternative medicine isn't supported by science, while completely sweeping under the rug all of the ways that mainstream medicine isn't supported by science. My concern isn't that the authors aren't mentioning specific issues, but rather that they're going out of their way to mislead their readers about the issues and the state of medicine more generally.

> That's an 18 year old source, talking about life expectancy, which is a trailing indicator.

It's the most recent data available. The fact that a lot of the data about the medical system is 20+ years old is in fact one of the biggest problems.

Also, I'm not in any way dismissing the contributions of modern medicine. As you say, modern medicine has contributed an enormous amount to society. Which makes it all the more unfortunate that many of its most vocal supporters wildly exaggerate its benefits and stick their heads in the sand when confronted with its problems. Making an intellectually honest argument in favor of modern medicine has to be one of the easiest tasks in the world, so the fact that so many of its supporters can't even do this doesn't say much for the quality of their ideas.

> Trying to prove that modern medicine has a net negative value because of a few issues of systemic corruption is not the way to do it.

I'm not trying to prove that it has net negative value. However, it's definitely not just a 'few' issues with systemic corruption.